Brand NameMoleculeApproval Date NCE DateNCE-1 DateInnovatorDosage FormStrengthTherapeutic CategoryUsageRevenue ($M)Projected Sales By 2028 ($M)CAGR (%)
BrenzavvybrenzavvyBexagliflozinbexagliflozin20-Jan-2320-Jan-2820-Jan-27THERACOSBIO LLCTablet20mgAntidiabeticTo Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus As An Adjunct To Diet And ExerciseNA6637648459281,015NANANABrenzavvy is an SGLT2 inhibitor that helps lower your average blood sugar level over 90 to 120 days. It’s FDA-approved to be used alongside diet and exercise to manage blood sugar in adults with type 2 diabetes.Who might benefit from taking Brenzavvy?Adults with type 2 diabetes who are looking to improve their blood sugar control alongside diet and exercise may benefit from Brenzavvy.What are the common side effects of Brenzavvy?Common side effects may include urinary tract infections, increased urination, and genital yeast infections.What is the generic for Brenzavvy?Bexagliflozin is the generic for BrenzavvyAre there any precautions or interactions while taking Brenzavvy?Brenzavvy may interact with certain medications affecting kidney function. It's important to inform your healthcare provider about all the medications you're taking.
JaypircajaypircaPirtobrutinibpirtobrutinib27-Jan-2327-Jan-2827-Jan-27LOXO ONCOLOGY INCTablet50mg,100mgAnticancerTo Treat Relapsed Or Refractory Mantle Cell Lymphoma In Adults Who Have Had At Least Two Lines Of Systemic Therapy, Including A BTK Inhibitor3376068911,1771,4641,9282,3322,76044.37%Jaypirca is a non-covalent BTK inhibitor used to treat adults with relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia after prior treatments. It’s taken orally once daily.What are the common side effects of Jaypirca?Common side effects of Jaypirca may include diarrhea, fatigue, and upper respiratory tract infections.How does Jaypirca work differently from other BTK inhibitors?Jaypirca is a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor. This means that it continues to work even when cancer cells develop resistance to traditional covalent BTK inhibitors.
OrserduorserduElacestrantelacestrant27-Jan-2327-Jan-2827-Jan-27STEMLINE THERAPEUTICS INCTabletEQ 86MG BASE,EQ 345MG BASEHormonal TherapyTo Treat Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated, Advanced Or Metastatic Breast Cancer With Disease Progression Following At Least One Line Of Endocrine TherapyNA6285898139174212NAOrserdu is a once-daily selective estrogen receptor degrader (SERD) approved for ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer in adults after endocrine therapy.
JesduvroqjesduvroqDaprodustatdaprodustat01-Feb-2301-Feb-2801-Feb-27GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLANDTablet1mg,2mg,4mg,6mg,8mgAntianemicTo Treat Anemia Caused By Chronic Kidney Disease For Adults On Dialysis For At Least Four MonthsNA72107134157174185192NAJesduvroq is an oral HIF-PHI approved for the treatment of anemia in adults with chronic kidney disease on dialysis. It was voluntarily withdrawn in the U.S. for non-safety-related reasons but remains FDA-listed.
FilsparifilspariSparsentansparsentan17-Feb-2317-Feb-2817-Feb-27TRAVERE THERAPEUTICSTablet200 mg and 400 mgAntiproteinuricTo Reduce Proteinuria In Adults With Primary Immunoglobulin1322954346438109931,1891,38657.39%Filspari is an oral dual endothelin and angiotensin receptor blocker approved to reduce proteinuria and slow kidney function decline in adults with IgA nephropathy.
SkyclarysskyclarysOmaveloxoloneomaveloxolone28-Feb-2328-Feb-2828-Feb-27REATA PHARMACEUTICALS INCCapsule50mgNeuroprotectiveFor The Treatment Of Friedreich Ataxia In Adults And Children 16 Years Of Age And Older.3835266727919081,0141,0891,14824.09%Skyclarys is the first FDA-approved treatment for Friedreich’s ataxia in patients aged 16 years and older. It helps reduce physical impairment associated with the condition.
ZavzpretzavzpretZavegepantzavegepant09-Mar-2309-Mar-2809-Mar-27PFIZER INCNasal Spray10MG BASE/SPRAYAntimigraineAcute Treatment Of Migraine With Or Without Aura In Adults.NA185248300334366396417NAZavzpret is a fast-acting nasal spray for the acute treatment of migraine in adults. It provides pain relief and functional recovery, with effects starting as early as 30 minutes after use.
DaybuedaybueTrofinetidetrofinetide10-Mar-2310-Mar-2810-Mar-27ACADIA PHARMACEUTICALS INCOral Solution200mg/mlNeuroprotectiveTo Treat Rett Syndrome In Adults And Children 2 Years And Older.34838946953660565871076314.83%Daybue is the first FDA-approved oral treatment for Rett syndrome in patients 2 years of age and older. It targets neurological function to address core symptoms of the disorder.
RezzayorezzayoRezafungin Acetaterezafungin-acetate22-Mar-2322-Mar-2822-Mar-27CIDARA THERAPEUTICS INCInjection- IV200MG BASE/VIALAntifungalTo Treat Candidemia And Invasive CandidiasisNA183554697992NANARezzayo is the first new echinocandin antifungal approved by the FDA in over 15 years for adults with limited or no alternative options for treating candidemia and invasive candidiasis. It works by inhibiting fungal β-glucan synthase, thereby disrupting cell wall synthesis, and simplifying care with once-weekly intravenous dosing.
JoenjajoenjaLeniolisibleniolisib24-Mar-2324-Mar-2824-Mar-27PHARMING TECHNOLOGIES BVTablet70MGImmunomodulatorsTo Treat Activated Phosphoinositide 3-Kinase Delta Syndrome456410314718923227331643.16%Joenja is the first FDA‑approved oral selective PI3Kδ inhibitor for activated phosphoinositide 3‑kinase delta (PI3Kδ) syndrome (APDS). It is administered to patients aged 12 years and older, targeting the underlying immune signaling defect in APDS to address both immunodeficiency and immune dysregulation.
QalsodyqalsodyTofersentofersen25-Apr-2325-Apr-2825-Apr-27BIOGEN MA INCSolution Intraethical100MG/15ML (6.7MG/ML)NeuroprotectiveTo Treat Amyotrophic Lateral Sclerosis In Adults Who Have A SOD1 Gene Mutation327910512414014014815744.63%Qalsody is the first FDA‑approved antisense oligonucleotide treatment for amyotrophic lateral sclerosis (ALS) associated with SOD1 gene mutations. It reduces SOD1 protein synthesis by targeting SOD1 mRNA, addressing disease progression at a genetic level.
VeozahveozahFezolinetantfezolinetant12-May-2312-May-2812-May-27ASTELLAS PHARMA US INCTablet45MGAnti-MenopausalTo Treat Moderate To Severe Hot Flashes Caused By Menopause2223314465787078369531,05333.59%Veozah is the first FDA‑approved non‑hormonal oral neurokinin 3 (NK3) receptor antagonist for moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause. It blocks neurokinin B activity in the hypothalamus to regulate body temperature without estrogen .
MiebomieboPerfluorhexyloctaneperfluorhexyloctane18-May-2318-May-2818-May-27BAUSCH AND LOMB INCEye Drops1.338GM/MLOphthalmicTo Treat Signs And Symptoms Of Dry Eye DiseaseNA116201309413NANANANAMiebo is an eye drop that treats dry eye disease by reducing tear evaporation. It forms a protective layer on the eye to keep it moist and comfortable.
XacduroxacduroSulbactam And Durlobactamsulbactam-and-durlobactam23-May-2323-May-2823-May-27ENTASIS THERAPEUTICS INCIV InjectionEQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIALAntibioticTo Treat Hospital-Acquired Bacterial Pneumonia And Ventilator-Associated Bacterial Pneumonia Caused By Susceptible Isolates Of Acinetobacter Baumannii-Calcoaceticus Complex245110918625833438243881.07%Xacduro is an IV antibiotic used for serious lung infections caused by resistant Acinetobacter bacteria. It combines two medicines to fight tough infections effectively.
PaxlovidpaxlovidNirmatrelvir And Ritonavirnirmatrelvir-and-ritonavir25-May-2325-May-2825-May-27PFIZER INCTablet150MG;100MG; 300MG; 100MGAntiviralTo Treat Mild-To-Moderate COVID-19 In Adults At High Risk For Progression To Severe COVID-195,7163,9163,8003,6753,5263,4013,2773,147-11.38%Paxlovid is an oral treatment for mild to moderate COVID-19 in high-risk patients. It stops the virus from multiplying and helps prevent severe illness when taken early.
PoslumaposlumaFlotufolastat F 18flotufolastat-f-1825-May-2325-May-2825-May-27BLUE EARTH DIAGNOSTICS LTDIntravenous Solution25ML (8-158mCi/ML)Diagnostic AgentsTo Use With Positron Emission Tomography Imaging In Certain Patients With Prostate CancerNANANANANANANANANAPosluma is a PSMA-targeted PET imaging agent used in prostate cancer. It helps doctors detect and locate primary and metastatic prostate tumors more accurately using a novel radiohybrid compound.
InpefainpefaSotagliflozinsotagliflozin26-May-2326-May-2826-May-27LEXICON PHARMACEUTICALS INCTablet200mg, 400mgCardiovascular AgentsTo Treat Heart Failure661228589814518576.33%Inpefa is a once-daily oral tablet for adults with heart failure, with or without type 2 diabetes or kidney disease. It reduces the risk of cardiovascular death, hospitalization, or urgent heart failure visits.
LitfulolitfuloRitlecitinibritlecitinib23-Jun-2323-Jun-2823-Jun-27PFIZER INCCapsule50MGImmunomodulatorsTo Treat Severely Patchy Hair LossNA113185264350423489540NALitfulo is an oral treatment for adults and adolescents aged 12 and older with severe alopecia areata. It helps regrow scalp hair by blocking immune pathways that attack hair follicles.
VanflytavanflytaQuizartinibquizartinib20-Jul-2320-Jul-2820-Jul-27DAIICHI SANKYO INCTablet17.7mg and 26.5 mg baseAnticancerTo Use As Part Of A Treatment Regimen For Newly Diagnosed Acute Myeloid Leukemia That Meets Certain Criteria3055739511813214815840.83%Vanflyta is an oral medicine used with chemotherapy for adults newly diagnosed with FLT3‑ITD positive acute myeloid leukemia. It continues working as a maintenance therapy to help keep the cancer in check.
XdemvyxdemvyLotilanerlotilaner25-Jul-2325-Jul-2825-Jul-27TARSUS PHARMACEUTICALS INCOphthalmic Drops0.25%AntiparasiticTo Treat Demodex Blepharitis1803374856687899201,0491,20944.69%Xdemvy is an eye drop treatment that targets and kills Demodex mites to treat blepharitis (eyelid inflammation). Apply twice daily for six weeks to clear up symptoms.
ZurzuvaezurzuvaeZuranolonezuranolone04-Aug-2304-Aug-2804-Aug-27BIOGEN INCCapsule20mg, 25mg and 30mgAntidepressantTo Treat Postpartum Depression7223235248760069377583869.90%Zurzuvae is a 14-day oral pill for adults with postpartum depression, offering rapid improvement in depressive symptoms. It helps new mothers regain mood balance after childbirth.
IzervayizervayAvacincaptad Pegolavacincaptad-pegol04-Aug-2304-Aug-2804-Aug-27IVERIC BIO INCIntravitreal SolutionEQ 2MG BASE/0.1MLOphthalmicTo Treat Geographic Atrophy Secondary To Age-Related Macular Degeneration3825848121,0261,2091,4181,5991,77533.38%Izervay is a monthly injection into the eye to treat geographic atrophy caused by age-related macular degeneration. It slows vision loss by targeting a key protein involved in retinal cell death.
SohonossohonosPalovarotenepalovarotene16-Aug-2316-Aug-2816-Aug-27IPSEN BIOPHARMACEUTICALS INCOral Capsules1mg, 1.5mg, 2.5mg, 5mg and 10mgAntiossificationTo Reduce The Volume Of New Heterotopic Ossification In Adults And Pediatric Patients (Aged 8 Years And Older For Females And 10 Years And Older For Males) With Fibrodysplasia Ossificans Progressiva232225303638434811.85%Sohonos is a daily oral capsule for patients (8 + for females, 10 + for males) with fibrodysplasia ossificans progressiva (FOP), a condition causing abnormal bone growth. It slows new bone formation by activating retinoic acid receptors.
AphexdaaphexdaMotixafortidemotixafortide08-Sep-2309-Aug-2809-Aug-27BIOLINERX LTDSubcutaneous Powder62MG BASE/VIALStem Cell MobilizerTo Use With Filgrastim (G-CSF) To Mobilize Hematopoietic Stem Cells To The Peripheral Blood For Collection And Subsequent Autologous Transplantation In Patients With Multiple MyelomaNANANANANANANANANAAphexda, used together with filgrastim, is a stem cell mobilizer for patients with multiple myeloma undergoing autologous transplant. By blocking CXCR4 receptors, it increases stem cells circulating in the blood for effective collection.
OjjaaraojjaaraMomelotinibmomelotinib15-Sep-2315-Sep-2815-Sep-27GLAXOSMITHKLINE LLCTablet100mg, 150mg and 200mgAnticancerTo Treat Intermediate Or High-Risk Myelofibrosis In Adults With Anemia4518041,0631,2511,4301,5851,7301,71833.44%Ojjaara is an oral medication for adults with intermediate or high-risk myelofibrosis and anemia. It targets JAK1, JAK2, and ACVR1 to reduce spleen size, relieve symptoms, and improve anemia.
ExxuaexxuaGepironegepirone22-Sep-2322-Sep-2822-Sep-27FABRE KRAMER PHARMACEUTICALS INCExtended Release Tablets18.2mg, 36.3mg, 54.5mg and 72.6mgAntidepressantTo Treat Major Depressive DisorderNA174688135165NANANAExxua is an extended-release oral antidepressant for adults with major depressive disorder. It selectively activates serotonin 5‑HT1A receptors, offering symptom relief with low risk of sexual side effects.
RivflozarivflozaNedosirannedosiran29-Sep-2329-Sep-2829-Sep-27NOVO NORDISK INCInjection80mg base /0.5ml, 128mg base/ 0.8ml, 160mg base/ 1mlAntimetabolic DisorderTo Lower Urinary Oxalate Levels In Patients 9 Years And Older With Primary Hyperoxaluria Type 1 And Relatively Preserved Kidney FunctionNA89141190216233242253NARivfloza is a once-monthly injection for children more than 2 years old and adults with primary hyperoxaluria type 1. It lowers urine oxalate levels by silencing a liver enzyme, helping protect kidney function.
VelsipityvelsipityEtrasimodetrasimod12-Oct-2312-Oct-2812-Oct-27PFIZER INCTablet2mg baseAntiulcerTo Treat Moderately To Severely Active Ulcerative Colitis In AdultsNA1743314686007368921,018NAVelsipity is a once-daily pill for adults with moderately to severely active ulcerative colitis. It modulates S1P receptors to reduce inflammation and maintain remission.
ZilbrysqzilbrysqZilucoplanzilucoplan17-Oct-2317-Oct-2817-Oct-27UCB INCSubcutaneous Injection16.6MG BASE/0.416ML, 23MG BASE/0.574ML, 32.4MG BASE/0.81MLImmunomodulatorsTo Treat Generalized Myasthenia Gravis In Adults Who Are Anti-Acetylcholine Receptor (AChR) Antibody Positive7818931542150557161963159.51%Zilbrysq is a once-daily self-administered injection for adults with generalized myasthenia gravis who test positive for anti-AChR antibodies. It blocks the complement C5 protein to reduce muscle weakness and improve strength.
AgamreeagamreeVamorolonevamorolone26-Oct-2326-Oct-2826-Oct-27CATALYST PHARMACEUTICALS INCOral Suspension40MG/MLNeuroprotectiveTo Treat Duchenne Muscular Dystrophy4614823129635338941944666.44%Agamree is an oral suspension for Duchenne muscular dystrophy in children aged 2 and older. It’s a steroid-type medicine that helps protect muscles and slow disease progression.
FruzaqlafruzaqlaFruquintinibfruquintinib08-Nov-2308-Nov-2808-Nov-27TAKEDA PHARMACEUTICALS USA INCCapsule1mg & 5mgAnticancerTo Treat Refractory, Metastatic Colorectal Cancer3543684264804704674875087.34%Fruzaqla is a once-daily oral treatment for metastatic colorectal cancer in adults who have already tried other therapies. It inhibits VEGF receptors to slow tumor growth and improve survival.
DefencathdefencathTaurolidine And Heparintaurolidine-and-heparin15-Nov-2315-Nov-2815-Nov-27CORMEDIX INCSingle Dose Vial To Instill In Central Venous Catheters3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML), 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)Antimicrobial And AnticoagulantTo Reduce The Incidence Of Catheter-Related Bloodstream Infections In Adults With Kidney Failure Receiving Chronic Hemodialysis Through A Central Venous CatheterNA165247274333341400457NADefencath is a catheter lock solution used in adult dialysis patients with central venous catheters. It helps prevent bloodstream infections by combining antimicrobial and anti-clotting effects.
AugtyroaugtyroRepotrectinibrepotrectinib15-Nov-2315-Nov-2815-Nov-27BRISTOL MYERS SQUIBB COCapsule40mgAnticancerTo Treat ROS1-Positive Non-Small Cell Lung Cancer3910719628636743448552675.15%Augtyro is an oral treatment for ROS1-positive non-small cell lung cancer and NTRK fusion–positive tumors. It blocks key cancer-driving proteins to help slow tumor growth, especially in patients who've tried other therapies.
TruqaptruqapCapIVasertibcapivasertib16-Nov-2316-Nov-2816-Nov-27ASTRAZENECA PHARMACEUTICALS LPTablet160mg and 200mgAnticancerTo Treat Breast Cancer That Meets Certain Disease Criteria4306338281,0491,2351,3991,5721,73530.18%Truqap is used with fulvestrant to treat certain advanced breast cancers with specific genetic mutations. It works by blocking the AKT pathway, which helps control tumor cell survival and growth.
OgsiveoogsiveoNirogacestatnirogacestat27-Nov-2327-Nov-2827-Nov-27SPRINGWORKS THERAPEUTICS INCTablet50mgAnticancerTo Treat Adults With Progressing Desmoid Tumors Who Require Systemic Treatment1721464005336718069741,06340.54%Ogsiveo is an oral therapy for adults with desmoid tumors that are actively progressing. It targets a protein involved in tumor formation, helping reduce tumor size and manage symptoms.
FabhaltafabhaltaIptacopaniptacopan05-Dec-2305-Dec-2805-Dec-27NOVARTIS PHARMACEUTICALS CORPCapsule200mgImmunomodulatorsTo Treat Paroxysmal Nocturnal Hemoglobinuria1294879851,4931,9452,3642,7653,12497.05%Fabhalta is an oral capsule that helps treat rare blood and kidney diseases by inhibiting complement factor B. It’s approved for adults with paroxysmal nocturnal hemoglobinuria (PNH), and to reduce proteinuria in complement 3 glomerulopathy (C3G) and IgA nephropathy.
FilsuvezfilsuvezBirch Triterpenesbirch-triterpenes18-Dec-2318-Dec-2818-Dec-27CHIESI FARMACEUTICI SPATopical Gel10%DermatologicTo Treat Wounds Associated With Dystrophic And Junctional Epidermolysis BullosaNANANANANANANANANAFilsuvez is a topical gel used on open wounds in patients with dystrophic or junctional epidermolysis bullosa (EB). It’s the first treatment that supports skin healing in this condition by promoting wound closure.
WainuawainuaEplonterseneplontersen21-Dec-2321-Dec-2821-Dec-27ASTRAZENECA ABSubcutaneous Injection45MG BASE/0.8MLNeuroprotectiveTo Treat Polyneuropathy Of Hereditary Transthyretin-Mediated Amyloidosis1053055359381,3581,8552,3022,74689.64%Wainua is a subcutaneous injection designed for adults managing nerve damage caused by hereditary transthyretin-mediated amyloidosis (ATTRv‑PN). It works via an antisense therapy that reduces the abnormal protein buildup damaging the nerves.
ZelsuvmizelsuvmiBerdazimerberdazimer05-Jan-2405-Jan-2905-Jan-28LNHC INCTopical GelEQ 10.3% BASEAntiviralTo Treat Molluscum ContagiosumNA161317242935NAZelsuvmi is a topical gel applied to molluscum contagiosum skin lesions in patients aged one year and older. The gel releases nitric oxide to clear lesions and is the only at-home prescription treatment for this viral infection.
ExblifepexblifepCefepime And Enmetazobactamcefepime-and-enmetazobactam22-Feb-2422-Feb-2922-Feb-28ALLECRA THERAPEUTICS SASIV PowderEQ 2GM BASE-VIAL;0.5GM-VIALAntibioticTo Treat Complicated Urinary Tract InfectionsNANANANANANANANANAExblifep is an antibiotic drug used in adults to treat complicated urinary tract infections, such as kidney infections, hospital-acquired pneumonia, including ventilator-associated pneumonia, and bacteraemia when associated or suspected to be associated with these infections.
RezdiffrarezdiffraResmetiromresmetirom14-Mar-2414-Mar-2914-Mar-28MADRIGAL PHARMACEUTICALS INCTablet60mg, 80mg, 100mgAntimetabolic DisorderTo Treat Noncirrhotic Non-Alcoholic Steatohepatitis With Moderate To Advanced Liver Scarring1806751,1261,7262,4633,4054,1514,84792.33%Rezdiffra is a prescription medication indicated for the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH) in individuals with mild to severe hepatic fibrosis. It is used to promote improved liver health in conjunction with a balanced diet and consistent exercise.
TryviotryvioAprocitentanaprocitentan19-Mar-2419-Mar-2919-Mar-28IDORSIA PHARMACEUTICALS LTDTablet12.5mgAntihypertensiveTo Treat HypertensionNA17314968838691NATryvio is an oral tablet that lowers blood pressure in adults whose hypertension isn’t managed well despite using multiple medications. It blocks endothelin receptors to relax blood vessels, reducing risks of stroke and heart attack.
DuvyzatduvyzatGivinostatgivinostat21-Mar-2421-Mar-2921-Mar-28ITALFARMACO SPAOral SuspensionEQ 8.86MG BASE-MLNeuromuscular AgentsTo Treat Duchenne Muscular Dystrophy In Individuals Aged 6 Years And OlderNA363393432484543600NANADuvyzat is an oral histone deacetylase inhibitor prescribed for Duchenne muscular dystrophy in patients aged six and older. It slows muscle degeneration, reduces inflammation, and supports muscle strength by modulating gene regulation processes.
VafseovafseoVadadustatvadadustat27-Mar-2427-Mar-2927-Mar-28AKEBIA THERAPEUTICS INCOral Tablets150mg, 300mg and 450mg tabletAntianemicTo Treat Anemia Due To Chronic Kidney Disease14102231312408518619730132.34%Vafseo is an oral tablet that treats anemia in adults with chronic kidney disease on dialysis by boosting natural erythropoietin production through HIF‑prolyl hydroxylase inhibition. It minimizes the need for blood transfusions while carrying a caution for cardiovascular and clotting risks .
VoydeyavoydeyaDanicopandanicopan29-Mar-2429-Mar-2929-Mar-28ALEXION PHARMACEUTICALS INCOral Tablets50mg and 100mgImmunomodulatorsTo Treat Extravascular Hemolysis With Paroxysmal Nocturnal HemoglobinuriaNA77145200253299341381NAVoydeya is an oral complement factor D inhibitor added to standard therapy in adults with paroxysmal nocturnal hemoglobinuria. It helps reduce ongoing hemolysis outside blood vessels, improving anemia.
ZevterazevteraCeftobiprole Medocaril Sodiumceftobiprole-medocaril-sodium03-Apr-2403-Apr-2903-Apr-28BASILEA PHARMACEUTICA INTERNATIONAL LTD ALLSCHWILIntravenous Powder Injection667MG-VIALAntibioticTo Treat Certain Bloodstream Infections, Bacterial Skin And Associated Tissue Infections, And Community-Acquired Bacterial PneumoniaNANANANANANANANANAZevtera is an advanced-generation cephalosporin antibiotic for treating Staphylococcus aureus bacteremia, including right-sided endocarditis, skin infections, and pneumonia in both adults and children. It works by blocking bacterial cell wall synthesis and remains active against MRSA and resistant strains.
LumisightlumisightPegulicianinepegulicianine17-Apr-2417-Apr-2917-Apr-28LUMICELL INCIntravenous Powder InjectionEQ 40MG BASE-VIALDiagnostic AgentsTo Use As An Optical Imaging Agent For The Detection Of Cancerous TissueNANANANANANANANANALumisight is an IV fluorescent imaging agent used during lumpectomy to highlight residual breast cancer tissue inside the surgical cavity. This real-time tool helps surgeons ensure more complete tumor removal and aims to lower the need for additional surgery.
OjemdaojemdaTovorafenibtovorafenib23-Apr-2423-Apr-2923-Apr-28DAY ONE BIOPHARMACEUTICALS INCOral Suspension25MG-MLAnticancerTo Treat Relapsed Or Refractory Pediatric Low-Grade Glioma5715625536349764177992471.84%Ojemda is the first FDA-approved targeted therapy for children 6 months and older with relapsed or treatment-resistant pediatric low-grade glioma (pLGG) caused by certain BRAF gene changes.
XolremdixolremdiMavorixaformavorixafor26-Apr-2426-Apr-2926-Apr-28X4 PHARMACEUTICALS INCOral Capsules100MGImmunomodulatorsTo Treat WHIM Syndrome (Warts, Hypogammaglobulinemia, Infections And Myelokathexis)32659107188378578763181.36%Xolremdi is a once-daily pill that helps people aged 12 years and older with WHIM syndrome by increasing important white blood cells to strengthen the body’s defense against infections.
RyteloryteloImetelstatimetelstat06-Jun-2406-Jun-2906-Jun-28GERON CORPIntravenous PowderEQ 47MG BASE-VIAL & EQ 188MG BASE-VIALAnticancerTo Treat Low- To Intermediate-1 Risk Myelodysplastic Syndromes772694847341,0671,3711,7042,02892.94%Rytelo is a prescription treatment for adults with low-to-intermediate-1 risk myelodysplastic syndromes (MDS) who have anemia and need frequent blood transfusions, and who haven't responded to or can't take erythropoiesis-stimulating agents (ESAs).
IqirvoiqirvoElafibranorelafibranor10-Jun-2410-Jun-2910-Jun-28IPSEN BIOPHARMACEUTICALS INCOral Tablets80MGHepatoprotective AgentsTo Treat Primary Biliary Cholangitis In Combination With Ursodeoxycholic Acid24137242353436515593649106.45%Iqirvo is used with ursodeoxycholic acid to treat primary biliary cholangitis. It works by targeting key pathways in the liver, including PPAR alpha and PPAR delta.
SofdrasofdraSofpironiumsofpironium18-Jun-2418-Jun-2918-Jun-28BOTANIX SB INCMetered Gel TopicalEQ 12.45% BASE (EQ 72MG BASE-ACTUATION)AntiperspirantTo Treat Primary Axillary HyperhidrosisNANANANANANANANANASofdra is a topical anticholinergic gel for adults and children aged 9 and up suffering from underarm excessive sweating (primary axillary hyperhidrosis). Applied at bedtime, it helps reduce sweat production by blocking signals to sweat glands
OhtuvayreohtuvayreEnsifentrineensifentrine26-Jun-2426-Jun-2926-Jun-28VERONA PHARMA INCSuspension; Inhalation3MG-2.5MLRespiratory AgentsTo Treat Chronic Obstructive Pulmonary Disease422495407459841,2941,6772,110120.01%Ohtuvayre is an inhaled medication for adults with moderate to severe COPD, offering a new option beyond traditional steroids and bronchodilators. It targets two enzymes (PDE3 and PDE4) to both open airways and reduce lung inflammation
LeqselvileqselviDeuruxolitinibdeuruxolitinib25-Jul-2425-Jul-2925-Jul-28SUN PHARMACEUTICAL INDUSTRIES INCOral Tablets8 mgImmunomodulatorsTo Treat Severe Alopecia Areata758125175231287342397139.68%Leqselvi is an oral tablet prescribed for adults with severe alopecia areata, a condition that causes widespread hair loss. It works by blocking specific Janus kinase enzymes involved in the autoimmune process, leading to significant hair regrowth over 30% of patients saw at least 80% scalp coverage in clinical trials
YorvipathyorvipathPalopegteriparatidepalopegteriparatide09-Aug-2409-Aug-2909-Aug-28ASCENDIS PHARMA BONE DISEASES ASSubcutaneous SolutionsEQ 0.168MG , EQ 0.294MG & EQ 0.42MGHormonal TherapyTo Treat Hypoparathyroidism313727451,1591,5541,8722,1182,413166.09%Yorvipath is used to treat hypoparathyroidism. It is a ready-to-use injection that is administered once a day to people with hypoparathyroidism.
VoranigovoranigoVorasidenibvorasidenib06-Aug-2406-Aug-2906-Aug-28SERVIER PHARMACEUTICALS LLCOral Tablets10 mg and 40 mgAnticancerTo Treat Grade 2 Astrocytoma Or OligodendrogliomaNA102134156167173177183NAVoranigo is an oral treatment for adults and teens with Grade 2 astrocytoma or oligodendroglioma that carry an IDH1 or IDH2 mutation, used after surgery. It blocks mutant IDH enzymes to slow tumor progression, significantly extending the time before disease worsens
LivdelzilivdelziSeladelparseladelpar14-Aug-2414-Aug-2914-Aug-28GILEAD SCIENCES INCCapsule10mgHepatoprotective AgentsTo Treat Primary Biliary Cholangitis (PBC)NA2415979421,3171,6381,8881,784NALivdelzi is used to treat primary biliary cholangitis (PBC). The purpose of Livdelzi is to efficiently target PPARδ, a peroxisome proliferator-activated receptor delta that inhibits the formation of bile acids.
LazcluzelazcluzeLazertiniblazertinib19-Aug-2419-Aug-2919-Aug-28JANSSEN BIOTECH INCOral Tablets80mg and 240mgAnticancerTo Treat Non-Small Cell Lung Cancer3276531,8613,4624,4425,4446,7197,73191.98%Lazcluze (lazertinib) is an oral targeted therapy used with amivantamab for adults with advanced EGFR-mutated non‑small cell lung cancer. This regimen blocks mutant EGFR to delay disease progression, extending median progression-free survival to about 23.7 months.
MiplyffamiplyffaArimoclomolarimoclomol20-Sep-2420-Sep-2920-Sep-28ZEVRA DENMARK ASOral Capsules47mg, 62mg, 93mg and 124mgNeuroprotectiveTo Treat Niemann-Pick Disease Type C1077144191225248267285117.79%Miplyffa is used to treat Niemann-Pick disease type C. The combination of the drug Miplyffa and miglustat is suggested for the treatment of neurological symptoms of Niemann-Pick disease type C in adults as well as children who are at least two years old.
AqneursaaqneursaLevacetylleucinelevacetylleucine24-Sep-2424-Sep-2924-Sep-28INTRABIO INCOral Suspension1gm-packetNeuroprotectiveTo Treat Niemann-Pick Disease Type CNANANANANANANANANAAqneursa is an oral granule formulation for patients aged 4 years and older with Niemann‑Pick disease type C. It improves neurological symptoms like coordination and balance by enhancing mitochondrial and lysosomal function and reducing cholesterol buildup in nerve cells.
CobenfycobenfyXanomeline And Trospium Chloridexanomeline-and-trospium-chloride26-Sep-2426-Sep-2926-Sep-28BRISTOL-MYERS SQUIBB COOral Capsules50mg, 100mg and 125mgAntipsychoticTo Treat Schizophrenia101664931,0091,7322,5253,1943,836262.77%Cobenfy is used to treat schizophrenia. It is the first and only FDA-approved medication for schizophrenia. This drug works by activating muscarinic acetylcholine receptors, which are small proteins in the brain.
FlyrcadoflyrcadoFlurpiridaz F 18flurpiridaz-f-1827-Sep-2427-Sep-2927-Sep-28GE HEALTHCARE INCIntravenous Injection5-55mCi-MLDiagnostic AgentsA Radioactive Diagnostic Drug To Evaluate For Myocardial Ischemia And InfarctionNANANANANANANANANAFlyrcado is an IV PET imaging agent for adults with known or suspected coronary artery disease. It highlights blood flow to the heart under rest or stress, helping doctors accurately detect ischemia or areas at risk of infarction.
ItovebiitovebiInavolisibinavolisib10-Oct-2410-Oct-2910-Oct-28GENENTECH INCOral Tablets3mg and 9mgAnticancerTo Treat Locally Advanced Or Metastatic Breast Cancer91573966929901,3211,6261,908223.85%Itovebi is an oral targeted therapy, added to palbociclib and fulvestrant, for HR-positive, HER2-negative advanced breast cancer with PIK3CA mutations. It inhibits mutant PI3Kα to slow tumor progression and extend progression-free survival.
OrlynvahorlynvahSulopenem Etzadroxil And Probenecidsulopenem-etzadroxil-and-probenecid25-Oct-2425-Oct-2925-Oct-28ITERUM THERAPEUTICS US LTDOral Tablets500mg; 500mgAntibioticTo Treat Uncomplicated Urinary Tract Infections (uUTI)NA1412306193117NAOrlynvah is an oral tablet for adult women with uncomplicated urinary tract infections caused by E. coli, K. pneumoniae, or P. mirabilis, especially for those with limited or no alternative oral antibiotic options. It combines sulopenem (an antibiotic) with probenecid, which helps increase sulopenem levels, delivering strong antibacterial activity comparable or superior to ciprofloxacin and amoxicillin/clavulanate in clinical trials.
RevuforjrevuforjRevumenib Citraterevumenib-citrate15-Nov-2415-Nov-2915-Nov-28SYNDAX PHARMACEUTICALS INCOral Tablets25mg, 110mg and 160mgAnticancerTo Treat Relapsed Or Refractory Acute Leukemia8100203323460584712849175.37%Revuforj is a drug used to treat relapsed or refractory acute leukemia. The treatment of acute leukemia is done with a lysine methyltransferase 2A gene translocation (KMT2A) in adults. This drug is also indicated for children 1 year and older whose disease has come back or has not improved after previous treatments.
AttrubyattrubyAcoramidisacoramidis22-Nov-2422-Nov-2922-Nov-28BRIDGEBIO PHARMA INCOral Tablets356 mgCardiovascular AgentsTo Treat Cardiomyopathy Of Wild-Type Or Variant Transthyretin-Mediated AmyloidosisNA3277121,1201,5131,7272,0302,315NAAttruby is an oral tablet for adults with transthyretin amyloid cardiomyopathy (wild-type or hereditary). It stabilizes misfolded transthyretin proteins, reducing the risk of heart-related death and hospitalization.
RapiblykrapiblykLandiolollandiolol22-Nov-2422-Nov-2922-Nov-28AOP ORPHAN PHARMACEUTICALS AGIntravenous Powder Injection280MG BASE-VIALCardiovascular AgentsTo Treat Supraventricular TachycardiaNANANANANANANANANARapiblyk is an IV beta-blocker used in hospitals to quickly control heart rate during acute supraventricular tachycardia (like atrial fibrillation or flutter). Its ultra-rapid action slows the heart without significantly lowering blood pressure.
IomervuiomervuIomeproliomeprol27-Nov-2427-Nov-2927-Nov-28BRACCO DIAGNOSTICS INCIntra-Arterial And Intravenous15gm/50ml, 17.5gm/50ml, 20gm/50ml, 25gm/100ml, 30gm/100ml, 35gm/100ml, 40gm/100ml, 60gm/150ml and 45gm/150mlDiagnostic AgentsFor Use As A Radiographic Contrast AgentNANANANANANANANANAIomervu is an injectable contrast agent for CT scans and angiography in adults and children. It enhances artery and organ imaging by providing clear, safe visualization of vascular structures.
CrenessitycrenessityCrinecerfontcrinecerfont13-Dec-2413-Dec-2913-Dec-28NEUROCRINE BIOSCIENCES INCOral Capsules25mg, 50mg and 100mgHormonal TherapyTo Treat Classic Congenital Adrenal HyperplasiaNA10126646866385410371,204NACrenessity is used to treat classic congenital adrenal hyperplasia. It is administered together with glucocorticoids to control androgen levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia.
EnsacoveensacoveEnsartinibensartinib18-Dec-2418-Dec-2918-Dec-28XCOVERY HOLDINGS INCOral Capsules25mg and 100mgAnticancerTo Treat Non-Small Cell Lung CancerNANANANANANANANANAEnsacove is an oral kinase inhibitor for adults with ALK-positive, locally advanced or metastatic non-small cell lung cancer who haven’t previously received ALK-targeted therapy. It blocks ALK-driven signaling to help control tumor growth and delay disease progression.
TryngolzatryngolzaOlezarsenolezarsen19-Dec-2419-Dec-2919-Dec-28IONIS PHARMACEUTICALS INCSubcutaneous SolutionEQ 80MG BASE/0.8MLAntihyperlipidemicTo Treat Familial Chylomicronemia SyndromeNA4098175308474632783NATryngolza is a subcutaneous injection for adults with familial chylomicronemia syndrome. It reduces APOC-III protein levels to lower dangerously high triglycerides and prevent pancreatitis.
AlyftrekalyftrekVanzacaftor, Tezacaftor, And DeutIVacaftorvanzacaftor-tezacaftor-and-deutivacaftor20-Dec-2420-Dec-2920-Dec-28VERTEX PHARMACEUTICALS INCOral Tablet50MG; 20MG; EQ 4MG BASE and 125MG; 50MG; EQ 10MG BASERespiratory AgentsTo Treat Cystic FibrosisNA7201,7542,5563,4254,2064,9145,604NAAlyftrek is a daily oral treatment for cystic fibrosis in patients aged 6 and older with the F508del mutation or other responsive CFTR variants. It helps restore CFTR protein function to improve lung performance and reduce disease flare-ups.
GrafapexgrafapexTreosulfantreosulfan21-Jan-2521-Jan-3021-Jan-29MEDEXUS PHARMA INCIntravenous Powder1GM/VIAL and 5GM/VIALAnticancerFor Use In Combination With Fludarabine As A Preparative Regimen For Allogeneic Hematopoietic Stem Cell Transplantation For Acute Myeloid Leukemia And Myelodysplastic SyndromeNANANANANANANANANAGrafapex is used with fludarabine to prepare adults and children (≥1 year) with AML or MDS for stem cell transplant. It helps replace traditional regimens, offering similar effectiveness with potentially fewer side effects
JournavxjournavxSuzetriginesuzetrigine30-Jan-2530-Jan-3030-Jan-29VERTEX PHARMACEUTICALS INCOral Tablet50MGAnticoagulantTo Treat Moderate To Severe Acute PainNA782916281,0821,5872,1332,585NAJournavx is a non‑opioid oral painkiller approved for adults with moderate‑to‑severe acute pain. It blocks sodium‑channel pain signals in the body, relieving pain without addiction risk.
GomekligomekliMirdametinibmirdametinib11-Feb-2511-Feb-3011-Feb-29SPRINGWORKS THERAPEUTICS INCOral Capsule And Oral Tablet, For Suspension1MG and 2MGAnticancerTo Treat Neurofibromatosis Type 1 Who Have Symptomatic Plexiform Neurofibromas Not Amenable To Complete ResectionNA41142319512699845969NAGomekli treats adults and children (≥2 years) with NF1-related plexiform neurofibromas that can't be fully removed. It inhibits MEK enzymes to slow tumor growth and reduce tumor size.
RomvimzaromvimzaVimseltinibvimseltinib14-Feb-2514-Feb-3014-Feb-29DECIPHERA PHARMACEUTICALS LLCOral Capsule14MG, 20MG and 30MGAnticancerTo Treat Symptomatic Tenosynovial Giant Cell Tumor For Which Surgical Resection Will Potentially Cause Worsening Functional Limitation Or Severe MorbidityNA3873105134160185209NARomvimza is a tablet for adults with tenosynovial giant cell tumor when surgery might worsen joint function. It blocks CSF-1R to shrink tumors and ease symptoms.
BlujepablujepaGepotidacingepotidacin25-Mar-2525-Mar-3025-Mar-29GLAXOSMITHKLINE LLCOral TabletEQ 750MG BASEAntibioticTo Treat Uncomplicated Urinary Tract InfectionsNA52167253345427497567NABlujepa treats uncomplicated urinary tract infections in females and adolescents with more than 12 years and more than or equal to 40 kg. It’s an oral antibiotic in a new class that combats common UTI bacteria and tackles antibiotic resistance.
QfitliaqfitliaFitusiranfitusiran28-Mar-2528-Mar-3028-Mar-29GENZYME CORPSubcutaneous SolutionEQ 20MG BASE/0.2ML and EQ 50MG BASE/0.5MLHemostatic AgentsTo Prevent Or Reduce The Frequency Of Bleeding Episodes In Hemophilia A Or BNA54189329448532595660NAQfitlia is a subcutaneous therapy approved for routine prevention of bleeding in patients aged 12 and older with hemophilia A or B, with or without inhibitors. It lowers antithrombin to rebalance clotting and has been shown to reduce annual bleeding rates by around 90%
VanrafiavanrafiaAtrasentanatrasentan02-Apr-2502-Apr-3002-Apr-29NOVARTIS PHARMACEUTICALS CORPOral TabletEQ 0.75MG BASENephroprotectiveTo Reduce Proteinuria In Adults With Primary Immunoglobulin A Nephropathy At Risk Of Rapid Disease ProgressionNA35136254396527656781NAVanrafia is an oral treatment for adults with primary IgA nephropathy at risk of rapid disease progression. It reduces proteinuria and helps protect kidney function by blocking endothelin A receptors.
Avmapki Fakzynja Co-Packavmapki-fakzynja-co-packAvutometinib And Defactinibavutometinib-and-defactinib08-May-2508-May-3008-May-29VERASTEM INCOral Capsule And TabletEQ 0.8MG BASE; EQ 200MG BASEAnticancerTo Treat KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) After Prior Systemic TherapyNA3192150268405540676NAAvmapki Fakzynja combines two oral kinase inhibitors for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer after prior systemic therapy. It targets both MEK and FAK pathways to help control tumor growth in patients with limited treatment options.
TryptyrtryptyrAcoltremonacoltremon28-May-2528-May-3028-May-29ALCON LABORATORIES, INCOphthalmic Solution/Drops0.003%OphthalmicTo Treat The Signs And Symptoms Of Dry Eye DiseaseNA73126218370NANANANATryptyr is an oral neuroactive steroid modulator designed to treat dry eye disease. It acts on nervous system pathways to relieve symptoms and improve eye comfort.
IbtroziibtroziTaletrectinibtaletrectinib11-Jun-2511-Jun-3011-Jun-29NUVATION BIO INCOral CapsuleEQ 200MG BASEAnticancerTo Treat Locally Advanced Or Metastatic ROS1-Positive Non-Small Cell Lung CancerNA956126207298386471NAIbtrozi is a targeted oral therapy for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. This selective ROS1 tyrosine kinase inhibitor received FDA approval in June 2025 with breakthrough therapy designation. Features enhanced CNS penetration for improved efficacy against brain metastases compared to earlier ROS1 inhibitors.
ZegfrovyzegfrovySunvozertinibsunvozertinib02-Jul-2502-Jul-3002-Jul-29DIZAL (JIANGSU) PHARMACEUTICAL CO LTDOral Tablet150MG and 200MGAnticancerTo Treat Locally Advanced Or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations, As Detected By An FDA-Approved Test, With Disease Progression On Or After Platinum-Based ChemotherapyNA1845118197279331356NAZegfrovy is a significant breakthrough in precision oncology for patients with non-small cell lung cancer (NSCLC) who have EGFR exon 20 insertion mutations. It sets a new benchmark for patients with few therapy alternatives by combining clinically significant efficacy, oral convenience, and highly selective EGFR inhibition. Its quick approval highlights the critical need for efficient treatments in this patient group, and further research attempts to increase its therapeutic benefit in first-line and combo treatment settings.
EkterlyekterlySebetralstatsebetralstat03-Jul-2503-Jul-3003-Jul-29KALVISTA PHARMACEUTICALS LTDOral Tablet300MGHereditary Angioedema AgentsTo Treat Acute Attacks Of Hereditary AngioedemaNA772174286395496590NAEkterly is the first and only oral, on-demand therapy for hereditary angioedema (HAE) attacks in patients aged 12 and older. It works by inhibiting plasma kallikrein, preventing excessive bradykinin production to reduce swelling rapidly. Approved in the U.S. and U.K. in 2025, Ekterly offers fast relief, convenient oral dosing, and a major advance over injectable treatments, giving patients greater independence and control during acute HAE episodes.
AnzupgoanzupgoDelgocitinibdelgocitinib23-Jul-2523-Jul-3023-Jul-29LEO PHARMA ASTopical Cream20MGDermatologicTo Treat Moderate-To-Severe Chronic Hand Eczema When Topical Corticosteroids Are Not Advisable Or Produce An Inadequate ResponseNANANANANANANANANAAnzupgo cream is the first and only topical pan-JAK inhibitor approved for adults with moderate to severe chronic hand eczema. By targeting the JAK-STAT pathway, it provides effective, steroid-free relief from inflammation, itching, and skin damage, giving patients a safer and more convenient alternative to traditional treatments.
SephiencesephienceSepiapterinsepiapterin28-Jul-2528-Jul-3028-Jul-29PTC THERAPEUTICS INCOral Powder250MG/PACKET and 1GM/PACKETAntimetabolic DisorderTo Treat Hyperphenylalaninemia In Patients With Sepiapterin-Responsive Phenylketonuria, In Conjunction With A Phenylalanine-Restricted DietNA21115213317405488516NASephience is the first and only oral phenylalanine hydroxylase activator approved for the treatment of hyperphenylalaninemia in adults and children with sepiapterin-responsive phenylketonuria. By delivering sepiapterin, which converts into tetrahydrobiopterin and also prevents PAH misfolding, it enhances enzyme function to reduce blood phenylalanine levels, offering patients a steroid-free, non-invasive, and more convenient alternative to dietary restriction alone.
VizzvizzAceclidineaceclidine31-Jul-2531-Jul-3031-Jul-29LENZ THERAPEUTICS INCOphthalmic Solution/DropsEQ 1.44% BASEAntiglaucoma AgentsTo Treat PresbyopiaNA456148213284357428NAVizz is the first and only aceclidine-based eye drop approved for adults with presbyopia. Presbyopia is an age-related blurry near vision. By selectively contracting the iris sphincter muscle to create a pinhole effect and achieve a sub-2 mm pupil—without significant ciliary muscle stimulation—it extends depth of focus to provide fast, steroid-free relief of near-vision blur that lasts up to 10 hours. It offers a safe, once-daily, non-surgical alternative to traditional reading glasses and contact lenses.
ModeysomodeysoDordavipronedordaviprone06-Aug-2506-Aug-3006-Aug-29CHIMERIX INCOral CapsuleEQ 125MG BASEAnticancerTo Treat Diffuse Midline Glioma Harboring An H3 K27M Mutation With Progressive Disease Following Prior TherapyNA347107180235298364NAModeyso is an oral protease activator approved for adults and children with recurrent H3 K27M-mutant diffuse midline glioma (DMG), a rare and aggressive brain tumor. By activating mitochondrial caseinolytic protease P (ClpP) and antagonizing dopamine D2 receptors, it induces stress-response pathways, apoptosis, and restoration of histone H3 trimethylation, ultimately slowing tumor growth. Taken once weekly on an empty stomach, Modeyso provides a systemic, non-invasive treatment option in an area where effective therapies have historically been limited.
HernexeoshernexeosZongertinibzongertinib08-Aug-2508-Aug-3008-Aug-29BOEHRINGER INGELHEIM PHARMACEUTICALS INCOral Tablet60MGAnticancerTo Treat Adults With Unresectable Or Metastatic Non-Squamous Non-Small Cell Lung Cancer Whose Tumors Have HER2 Tyrosine Kinase Domain Activating Mutations, As Detected By An FDA-Approved Test, And Who Have Received Prior Systemic TherapyNANA51124384752NAHernexeos is an oral tyrosine kinase inhibitor used to treat adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. Treatment is indicated following prior systemic therapy, and eligibility requires confirmation of the HER2 mutation via an FDA-approved test.
BrinsupribrinsupriBrensocatibbrensocatib12-Aug-2512-Aug-3012-Aug-29INSMED INCOral Tablet10MG and 25MGRespiratory AgentsTo Treat Non-Cystic Fibrosis BronchiectasisNA424899961,6292,4253,1793,884NABrinsupri is an oral, once-daily dipeptidyl peptidase-1 (DPP1) inhibitor for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adults and adolescents aged 12 years and older. It represents the first FDA-approved targeted therapy for this chronic, progressive lung disease, directly addressing neutrophil-driven inflammation rather than just symptom management.
DawnzeradawnzeraDonidalorsendonidalorsen21-Aug-2521-Aug-3021-Aug-29IONIS PHARMACEUTICALS, INCInjection80MGHereditary Angioedema AgentsTo Prevent Attacks Of Hereditary AngioedemaNA1577168261331401470NADawnzera is an RNA-targeted antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. It works by selectively reducing prekallikrein production, thereby lowering bradykinin formation, to significantly reduce the frequency and severity of swelling episodes. The drug is administered via a subcutaneous autoinjector every 4 weeks, offering a convenient self-injectable prophylactic option for this serious condition.
WayrilzwayrilzRilzabrutinibrilzabrutinib29-Aug-2529-Aug-3029-Aug-29GENZYME CORPOral Tablet400MGImmunomodulatorsTo Treat Persistent Or Chronic Immune Thrombocytopenia That Has Not Sufficiently Responded To Immunoglobulins, Anti-D Therapy, Or CorticosteroidsNA23133223345445562677NAWayrilz is an oral reversible BTK inhibitor indicated for adults with chronic immune thrombocytopenia (ITP). It works by modulating immune pathways to increase platelet counts and reduce the risk of bleeding, offering a convenient twice-daily oral treatment option.
ForzinityforzinityElamipretideelamipretide19-Sep-2519-Sep-3019-Sep-29STEALTH BIOTHERAPEUTICS INCSubcutaneous SolutionEQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)Mitochondrial Dysfunction AgentTo Improve Muscle Strength In Patients With Barth Syndrome Weighing At Least 30 KgNANANANANANANANANAForzinity is a mitochondrial-targeted therapy for Barth syndrome in patients weighing 30 kg or more. It stabilizes mitochondrial function to improve energy production and muscle strength, administered via subcutaneous injection.
InluriyoinluriyoImlunestrantimlunestrant25-Sep-2525-Sep-3025-Sep-29ELI LILLY AND COMPANYOral Tablet200MGAnticancerTo Treat Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Estrogen Receptor-1-Mutated Advanced Or Metastatic Breast Cancer With Disease Progression Following At Least One Line Of Endocrine TherapyNA9143236341445539630NAInluriyo is an oral selective estrogen receptor degrader (SERD) indicated for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. It degrades estrogen receptors to block tumor growth, offering a convenient daily oral option.
PalsonifypalsonifyPaltusotinepaltusotine25-Sep-2525-Sep-3025-Sep-29CRINETICS PHARMA INCOral Tablet20MG and 30MGHormonal TherapyTo Treat Acromegaly In Adults Who Had An Inadequate Response To Surgery And/Or For Whom Surgery Is Not An OptionNA552121213346469621NAPalsonify is an oral somatostatin receptor agonist approved for adults with acromegaly. It suppresses excess growth hormone and IGF-1 levels, providing a once-daily, non-injectable alternative to traditional therapies.
RhapsidorhapsidoRemibrutinibremibrutinib30-Sep-2530-Sep-3030-Sep-29NOVARTIS PHARMS CORPOral Tablet25MGImmunomodulatorsTo Treat Chronic Spontaneous Urticaria In Adults Who Remain Symptomatic Despite H1 Antihistamine TreatmentNA292385549341,2931,6361,931NARhapsido is an oral BTK inhibitor indicated for chronic spontaneous urticaria (CSU). By blocking mast cell activation and histamine release, it effectively reduces hives and itch in patients unresponsive to antihistamines.
Brand NameMoleculeApproval Date Market Exclusivity ExpiryData Exclusivity ExpiryInnovatorDosage FormStrengthTherapeutic CategoryUsageRevenue ($M)Projected Sales By 2028 ($M)CAGR (%)
LeqembileqembiLecanemab-Irmblecanemab-irmb06-Jan-2306-Jan-3506-Jan-27EISAI INC.Injection500 mg/5 mL (100 mg/mL), 200 mg/2 mL (100 mg/mL)AntialzheimerTo Treat Alzheimer’s Disease3127681,2821,9882,7883,5974,3384,99372.90%Leqembi is a prescription medicine for early-stage Alzheimer’s disease. It’s a monoclonal antibody that helps reduce amyloid plaques in the brain and is the first treatment of its kind approved in the European Union.What is Leqembi and how does it work?Leqembi is a monoclonal antibody treatment for early-stage Alzheimer's disease. It works by targeting and reducing amyloid plaques in the brain, potentially helping to slow cognitive decline in patients with mild cognitive impairment or mild dementia.Who is eligible for Leqembi treatment?Leqembi is for patients with early-stage Alzheimer's disease, specifically mild cognitive impairment or mild dementia. Patients must have confirmed elevated beta-amyloid in the brain through testing like PET scans or spinal fluid analysis.How is Leqembi administered?Leqembi is given as an IV infusion every two weeks at a healthcare facility. Each session requires medical supervision and regular monitoring by healthcare professionals.What are the potential side effects and monitoring requirements?The most common side effects of LEQEMBI include infusion-related reactions, ARIA, and headaches.
LamzedelamzedeVelmanase Alfa-Tycvvelmanase-alfa-tycv16-Feb-2316-Feb-3516-Feb-27CHIESI FARMACEUTICI S.P.A.Injection- IV10 mgAntimetabolic DisorderTo Treatment Of Non-Central Nervous System Manifestations Of Alpha-Mannosidosis In Adult And Pediatric Patients.NANANANANANANANANALamzede is the first enzyme replacement therapy for non-central nervous system manifestations of alpha-mannosidosis. It improves enzyme activity and reduces the buildup of serum oligosaccharides.
ZynyzzynyzRetifanlimab-Dlwrretifanlimab-dlwr22-Mar-2322-Mar-3522-Mar-27INCYTEIntravenous Injection500mg/20mlAnticancerIt Is Indicated For The Treatment Of Adult Patients With Metastatic Or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC).3195599134166198223158.52%Zynyz is the first PD‑1 inhibitor approved by the FDA for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. It is now available both as monotherapy and in combination with platinum‑based chemotherapy, and is also approved for metastatic Merkel cell carcinoma; it enhances T‑cell activity to target and slow tumor growth.
ElfabrioelfabrioPegunigalsidase Alfa-Iwxjpegunigalsidase-alfa-iwxj09-May-2309-May-3509-May-27PROTALIX BIOTHERAPEUTICS, INC.Injection20mg/10mlAntimetabolic DisorderTo Treat Confirmed Fabry DiseaseNA29NANANANA50NANAElfabrio is the first PEGylated enzyme replacement therapy approved by the FDA for adults with Fabry disease. It provides exogenous alpha‑galactosidase A to reduce globotriaosylceramide accumulation and improve organ function.
EpkinlyepkinlyEpcoritamab-Byspepcoritamab-bysp19-May-2319-May-3519-May-27GENMAB AND ABBVIEInjection4 mg/0.8 mL and 48 mg/0.8 mLAnticancerTo Treat Relapsed Or Refractory Diffuse Large B-Cell Lymphoma (Not Otherwise Specified) And High-Grade B-Cell Lymphoma After Two Or More Lines Of Systemic Therapy3997341,2361,9712,6083,1903,6684,08059.89%Epkinly is an injection used for certain types of blood cancer like large B-cell lymphoma. It helps immune cells find and destroy cancer cells.
ColumvicolumviGlofitamab-Gxbmglofitamab-gxbm15-Jun-2315-Jun-3515-Jun-27ROCHEIV Injection2.5mg/2.5ml and 10mg/10mlAnticancerTo Treat Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Or Large B-Cell Lymphoma Arising From Follicular Lymphoma After Two Or More Lines Of Systemic Therapy1953876248901,1631,3941,6181,84056.27%Columvi is an antibody-based therapy for adults with relapsed or refractory diffuse large B-cell lymphoma. It activates the immune system to target and destroy cancer cells when other treatments have failed.
RystiggorystiggoRozanolixizumab-Nolirozanolixizumab-noli26-Jun-2326-Jun-3526-Jun-27UCBSubcutaneous Injection280mg/2mlImmunomodulatorsTo Treat Generalized Myasthenia Gravis In Adults Who Are Anti-Acetylcholine Receptor- Or Anti-Muscle-Specific Tyrosine Kinase Antibody-Positive21930040949155961967171226.40%Rystiggo is a weekly subcutaneous infusion for adults with generalized myasthenia gravis. It lowers harmful antibodies that disrupt communication between nerves and muscles.
NgenlangenlaSomatrogon-Ghlasomatrogon-ghla27-Jun-2327-Jun-3527-Jun-27OPKO/PFIZERPrefilled Injection24mg and 60mgHormonal TherapyTo Treat Growth Failure Due To Inadequate Secretion Of Endogenous Growth HormoneNA110196255331399457508NANgenla is an injection of long-acting growth hormone, administered once a week, for children 3 years and older with growth hormone deficiency. It helps support normal growth using a prefilled pen system.
BeyfortusbeyfortusNirsevimab-Alipnirsevimab-alip17-Jul-2317-Jul-3517-Jul-27SANOFIIntramuscular Injection100mg/ 1ml and 50mg/ 0.5mlAntiviralTo Prevent Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease2,3462,6062,9143,1683,3823,5363,6993,8629.57%Beyfortus is a single-dose antibody given to newborns and infants to prevent serious RSV (respiratory syncytial virus) lung infections during their first two RSV seasons. It reduces hospitalizations by about 70 to 80%.
TalveytalveyTalquetamab-Tgvstalquetamab-tgvs09-Aug-2309-Aug-3509-Aug-27JANSSEN BIOTECH, INC.Subcutaneous Injection2mg/ml and 40mg/mlAnticancerTo Treat Adults With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least Four Prior Therapies2874577401,0631,3911,6291,7711,95948.38%Talvey is a bispecific antibody injection for adults with multiple myeloma who have already tried at least four other treatments. It helps the immune system target and kill myeloma cells.
ElrexfioelrexfioElranatamab-Bcmmelranatamab-bcmm14-Aug-2314-Aug-3514-Aug-27PFIZERSubcutaneous Injection44mg/1.1ml and 76mg/ 1.9mlAnticancerTo Treat Adults With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least Four Prior Lines Of Therapy1333264696398149721,1071,22357.29%Elrexfio is a weekly subcutaneous injection for adults with relapsed or refractory multiple myeloma who have tried at least four prior treatments. It’s a bispecific antibody that directs T cells to attack myeloma cells by targeting BCMA and CD3.
VeopozveopozPozelimab-Bbfgpozelimab-bbfg18-Aug-2318-Aug-3518-Aug-27REGENERON PHARMACEUTICALS, INC.IV Infusion400mg/2mlImmunomodulatorsTo Treat Patients 1 Year Old And Older With CD55-Deficient Protein-Losing Enteropathy (PLE), Also Known As CHAPLE DiseaseNANA966153232292332NAVeopoz is an antibody injection that treats CHAPLE disease, a rare genetic disorder causing protein loss and chronic intestinal inflammation. It works by blocking complement C5, helping to stabilize protein levels and reduce hospital visits in both children and adults.
PombilitipombilitiCipaglucosidase Alfa-Atgacipaglucosidase-alfa-atga28-Sep-2328-Sep-3528-Sep-27AMICUS THERAPEUTICSIV Infusion105mg/vialAntimetabolic DisorderTo Treat Late-Onset Pompe Disease7011320630640249058567954.80%Pombiliti, used with Opfolda (miglustat), treats adults with late-onset Pompe disease who aren’t responding to enzyme replacement therapy. It delivers an enzyme to break down muscle-accumulated glycogen, improving muscle strength and lung function.
BimzelxbimzelxBimekizumabbimekizumab17-Oct-2317-Oct-3517-Oct-27UCB INCInjection160mg/mlImmunomodulatorsTo Treat Moderate To Severe Plaque Psoriasis In Adults Who Are Candidates For Systemic Therapy Or Phototherapy6571,4652,3603,3604,2064,8825,4425,92259.07%Bimzelx is a subcutaneous injection used to treat plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis), and hidradenitis suppurativa. It targets and blocks IL‑17A and IL‑17F cytokines to reduce inflammation and skin/joint symptoms.
OmvohomvohMirikizumab-Mrkzmirikizumab-mrkz26-Oct-2326-Oct-3526-Oct-27ELI LILLYIV Infusion300mg/15mlAntiulcerTo Treat Ulcerative Colitis1322915646898199291,0261,11757.83%Omvoh is a once-daily oral antibody for adults with moderately to severely active ulcerative colitis. It targets inflammatory pathways to reduce bowel inflammation and improve symptoms.
LoqtorziloqtorziToripalimab-Tpzitoripalimab-tpzi27-Oct-2327-Oct-3527-Oct-27COHERUS BIOSCIENCESIV Infusion40mg/mlAnticancerTo Treat Recurrent Or Metastatic Nasopharyngeal Carcinoma When Used Together With Or Following Other Therapies1950759011013015017055.12%Loqtorzi is an IV antibody used alongside other treatments for recurrent or metastatic nasopharyngeal carcinoma. It helps the immune system recognize and attack cancer cells.
RyzneutaryzneutaEfbemalenograstim Alfa-Vuxwefbemalenograstim-alfa-vuxw16-Nov-2316-Nov-3516-Nov-27EVIVE BIOTECHNOLOGYInjection20MG/MLHematopoietic Growth FactorTo Treat NeutropeniaNANANANANANANANANARyzneuta is an injection that supports white blood cell production in cancer patients undergoing chemotherapy. It helps lower the risk of infection-related complications by boosting the immune system.
LetyboletyboLetibotulinumtoxina-Wlbgletibotulinumtoxina-wlbg29-Feb-2429-Feb-3629-Feb-28HUGEL, INC.IM Injection50 units per vial and 100 units per vialDermatologicTo Temporarily Improve The Appearance Of Moderate-To-Severe Glabellar LinesNANANANANANANANANALetybo is an injectable neurotoxin used to soften frown lines between the eyebrows by temporarily relaxing the muscles responsible. It works by blocking acetylcholine release at the neuromuscular junction, reducing muscle contractions and smoothing wrinkles.
TevimbratevimbraTislelizumab-Jsgrtislelizumab-jsgr13-Mar-2413-Mar-3613-Mar-28BEIGENE, LTD.IV Injection100mg-10mlAnticancerTo Treat Unresectable Or Metastatic Esophageal Squamous Cell Carcinoma6217428721,0381,1711,2681,3651,46017.18%Tevimbra contains Tislelizumab, a monoclonal antibody that is indicated for the treatment of unresectable or metastatic small-cell lung cancer and gastric adenocarcinoma in adult patients. It can be given as a first line in combination with other chemotherapeutic agents, and also to patients who have previously received chemotherapy.
WinrevairwinrevairSotatercept-Csrksotatercept-csrk26-Mar-2426-Mar-3626-Mar-28MERCK & CO., INC. (MSD)Subcutaneous Injection45 mg lyophilized cake or powder, 60 mg lyophilized cake or powderAntihypertensiveTo Treat Pulmonary Arterial Hypertension4191,7462,9264,1455,1666,1306,9467,66987.39%Winrevair is used to treat adults with pulmonary arterial hypertension (PAH). It helps improve exercise ability, daily functioning, and lowers the risk of the condition getting worse.
AnktivaanktivaNogapendekin Alfa Inbakicept-Pmlnnogapendekin-alfa-inbakicept-pmln22-Apr-2422-Apr-3622-Apr-28LMMUNITYBIO, INC.Intravesical Injection400 mcg-0.4 mLAnticancerTo Treat Bladder Cancer14702065201,1832,1223,5795,649203.19%Anktiva is the first FDA-approved immunotherapy that activates the immune system to treat BCG-unresponsive non-muscle invasive bladder cancer (CIS), offering some patients a lasting complete response.
ImdelltraimdelltraTarlatamab-Dlletarlatamab-dlle16-May-2416-May-3616-May-28AMGENIntravenous Infusion1mg-vial and 10mg-vialAnticancerTo Treat Extensive Stage Small Cell Lung Cancer1155367931,0441,3881,6161,6882,02986.39%Imdelltra is used to treat adults with extensive-stage small cell lung cancer (ES-SCLC) that has returned after platinum-based chemotherapy.
PiaskypiaskyCrovalimab-Akkzcrovalimab-akkz20-Jun-2420-Jun-3620-Jun-28GENENTECHIntravenous Infusion340mg-2mlImmunomodulatorsTo Treat Paroxysmal Nocturnal Hemoglobinuria18110212302379455526592114.21%Nemluvio is an injectable antibody for adults suffering from debilitating itch in prurigo nodularis or moderate-to-severe atopic dermatitis. It blocks the IL‑31 receptor to reduce itching and improve skin healing, offering relief within 48 hours.
KisunlakisunlaDonanemab-Azbtdonanemab-azbt02-Jul-2402-Jul-3602-Jul-28ELI LILLYIntravenous Infusion350mg- 20mlAntialzheimerTo Treat Alzheimer’s Disease92835617119271,1821,4011,580218.57%Kisunla is used to treat Alzheimer’s disease. It is an FDA-approved treatment for early symptomatic Alzheimer's disease, including mild cognitive impairment and the mild dementia stage of the condition.
NemluvionemluvioNemolizumab-Iltonemolizumab-ilto12-Aug-2412-Aug-3612-Aug-28CHUGAI PHARMACEUTICAL CO., LTD.Prefilled Pen For Injection30mgImmunomodulatorsTo Treat Prurigo Nodularis232395719991,5242,0622,5213,017185.31%Nemluvio is an injectable antibody for adults suffering from debilitating itch in prurigo nodularis or moderate-to-severe atopic dermatitis. It blocks the IL‑31 receptor to reduce itching and improve skin healing, offering relief within 48 hours.
NiktimvoniktimvoAxatilimab-Csfraxatilimab-csfr14-Aug-2414-Aug-3614-Aug-28INCYTE CORPORATIONIntravenous Infusion50mg-ml , 9mg- 0.18ml and 22mg-0.44 mlImmunomodulatorsTo Treat Chronic Graft-Versus-Host Disease (cGVHD)NA103201312432533629698NANiktimvo is an IV antibody treatment for adults and children (≥ 40 kg) with chronic graft‑versus‑host disease whose condition worsened despite at least two prior therapies. It works by blocking CSF‑1R to calm overactive immune cells and reduce symptoms.
EbglyssebglyssLebrikizumab-Lbkzlebrikizumab-lbkz13-Sep-2413-Sep-3613-Sep-28ELI LILLYPrefilled Pen Subcutaneous Injection250mgImmunomodulatorsTo Treat Moderate-To-Severe Atopic Dermatitis794239061,2781,6942,1532,4932,819115.19%Ebglyss is used to treat moderate-to-severe atopic dermatitis. It addresses the inflammation caused by eczema all over your body, resulting in persistently dry, itchy, and irritated skin.
HympavzihympavziMarstacimab-Hncqmarstacimab-hncq11-Oct-2411-Oct-3611-Oct-28PFIZERInjection150mg-mlHemostatic AgentsTo Prevent Or Reduce Bleeding Episodes Related To Hemophilia A Or BNA52111161206252294332NAHympavzi is a subcutaneous antibody given to patients aged 12 and older to prevent bleeding episodes in hemophilia A or B without factor inhibitors. It works by inhibiting the tissue factor pathway to reduce the frequency of bleeds.
VyloyvyloyZolbetuximab-Clzbzolbetuximab-clzb18-Oct-2418-Oct-3618-Oct-28ASTELLAS PHARMA US, INC.Intravenous Infusion100mg-vialAnticancerTo Treat Gastric Or Gastroesophageal Junction Adenocarcinoma803024256087658919841,07275.85%Vyloy is used with fluoropyrimidine and platinum-based chemotherapy as the first-line treatment for HER2-negative gastric or gastroesophageal junction cancer, which cannot be removed by surgery or has spread and tests positive for claudin (CLDN)18.2.
ZiiheraziiheraZanidatamab-Hriizanidatamab-hrii20-Nov-2420-Nov-3620-Nov-28JAZZ PHARMACEUTICALSIntravenous Infusion30mg-vialAnticancerTo Treat Unresectable Or Metastatic HER2-Positive (IHC 3+) Biliary Tract Cancer12992235376555790981340.35%Ziihera is the first and only approved bispecific antibody drug. It treats unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. This drug is given to patients who have already received the other chemotherapeutic treatment.
BizengribizengriZenocutuzumab-Zbcozenocutuzumab-zbco04-Dec-2404-Dec-3604-Dec-28MERUS N.V.Injection375MG/18.75MLImmunomodulatorsTo Treat Non-Small Cell Lung Cancer And Pancreatic AdenocarcinomaNA630100164217260306NABizengri is an IV antibody therapy for adults with advanced non-small cell lung cancer or pancreatic cancer driven by NRG1 gene fusions, used after standard treatments fail. It blocks the fusion protein’s signaling to help shrink tumors and control disease progression
UnloxcytunloxcytCosibelimab-Ipdlcosibelimab-ipdl13-Dec-2413-Dec-3613-Dec-28CHECKPOINT THERAPEUTICS INCInjection300MG/5ML(60MG/ML)AnticancerTo Treat Cutaneous Squamous Cell CarcinomaNA3674159256402543707NAUnloxcyt is an IV anti–PD-L1 antibody for adults with advanced or metastatic cutaneous squamous cell carcinoma who are not surgical or radiation candidates. It helps the immune system fight cancer by blocking PD-L1, with a documented response in nearly half of patients.
AlhemoalhemoConcizumab-Mtciconcizumab-mtci20-Dec-2420-Dec-3620-Dec-28NOVO NORDISK INCSubcutenous Injection60MG/1.5ML, 150MG/1.5ML and 300MG/3MLHemostatic AgentsFor Routine Prophylaxis To Prevent Bleeding Episodes In Hemophilia A And BNA56100145191212226247NAAlhemo is a preventive injection for people with hemophilia A or B with inhibitors, aged 12 and above. It helps reduce and prevent bleeding episodes by regulating the clotting pathway.
DatrowaydatrowayDatopotamab Deruxtecan-Dlnkdatopotamab-deruxtecan-dlnk17-Jan-2517-Jan-3717-Jan-29DAIICHI SANKYO INCIntravenous Injection100MGAnticancerTo Treat Unresectable Or Metastatic, HR-Positive, HER2-Negative Breast Cancer Who Have Received Prior Endocrine-Based Therapy And Chemotherapy For Unresectable Or Metastatic Disease91836441,4612,2103,0353,7724,507295.86%Datroway is an antibody-drug conjugate for adults with advanced non-small cell lung cancer that has an EGFR mutation and progressed after standard treatment. It delivers targeted chemotherapy directly to cancer cells to control tumor growth.
Penpulimab-Kcqxpenpulimab-kcqxPenpulimab-Kcqxpenpulimab-kcqx23-Apr-2523-Apr-3723-Apr-29AKESO BIOPHARMA CO., LTDIntravenous Injection100MG/10ML(10MG/ML)AnticancerIn Combination With Either Cisplatin Or Carboplatin And Gemcitabine, To Treat Adults With Recurrent Or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma (NPC), Or As A Single Agent While On Or After Platinum-Based Chemotherapy And At Least One Other Prior Line Of TherapyNA7989101109117127132NAPenpulimab‑Kcqx is an intravenous PD‑1 inhibitor used with chemotherapy to treat recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. It boosts immune response to help control tumor growth in patients who have progressed after prior therapies.
ImaavyimaavyNipocalimab-Aahunipocalimab-aahu29-Apr-2529-Apr-3729-Apr-29JANSSEN BIOTECH, INC.Injection300MG/1.62ML and 1200MG/6.5MLImmunomodulatorsTo Treat Generalized Myasthenia GravisNA4131,0311,5472,0112,5143,0163,469NAImaavy is an IV antibody for adults and teens aged 12 and older with generalized myasthenia gravis who test positive for AChR or MuSK antibodies. It targets and blocks the FcRn receptor to reduce harmful autoantibodies and improve muscle strength.
EmrelisemrelisTelisotuzumab Vedotin-Tllvtelisotuzumab-vedotin-tllv14-May-2514-May-3714-May-29ABBVIE INCSingle-Dose Vial20MG and 100MGAnticancerTo Treat Locally Advanced Or Metastatic, Non-Squamous Non-Small Cell Lung Cancer (NSCLC) With High C-Met Protein Overexpression After Prior Systemic TherapyNA2399232418576724876NAEmrelis is an antibody‑drug conjugate for adults with locally advanced or metastatic non-squamous non-small cell lung cancer overexpressing c‑Met after prior therapy. It delivers targeted chemotherapy directly to cancer cells to inhibit tumor progression.
EnflonsiaenflonsiaClesrovimab-Cforclesrovimab-cfor09-Jun-2509-Jun-3709-Jun-29MERCK SHARP & DOHME LLCInjection105MG/0.7MLImmunomodulatorsTo Prevent Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease In Neonates And Infants Who Are Born During Or Entering Their First RSV SeasonNA922314446347919221,041NAENFLONSIA is a long-acting, preventive monoclonal antibody developed to protect infants against a broad range of respiratory syncytial virus (RSV) disease severity. This includes severe cases that may lead to hospitalization. It is the first and only RSV preventive option that offers a weight-independent, single-dose administration, simplifying protection across all infants regardless of size or gestational age. ENFLONSIA provides consistent, season-long immunity with a convenient, once-per-season approach.
AndembryandembryGaradacimab-Gxiigaradacimab-gxii16-Jun-2516-Jun-3716-Jun-29CSL BEHRING LLCSubcutaneous Injection200MG/1.2MLHereditary Angioedema AgentsTo Prevent Attacks Of Hereditary AngioedemaNA129202256364501531567NAAndembry is a preventive therapy for hereditary angioedema (HAE) in adults and adolescents 12+ years. This selective Factor XIIa inhibitor targets the top of the inflammatory cascade with once-monthly dosing. FDA-approved in June 2025, offering the first monthly prophylactic HAE treatment targeting Factor XIIa.
LynozyficlynozyficLinvoseltamab-Gcptlinvoseltamab-gcpt02-Jul-2502-Jul-3702-Jul-29REGENERON PHARMACEUTICALS, INC.Injection5MG/2MLAnticancerTo Treat Relapsed Or Refractory Multiple Myeloma After At Least Four Prior Lines Of Therapy, Including A Proteasome Inhibitor, An Immunomodulatory Agent, And An Anti CD38 Monoclonal AntibodyNA34127240361477569662NALynozyfic is a monotherapy for adults with relapsed and refractory multiple myeloma after ≥3 prior therapies. This bispecific T-cell engager bridges CD3 on T-cells with BCMA protein on myeloma cells to activate cancer-cell killing. FDA and EMA approved for heavily pretreated patients who have exhausted standard treatment options.
Keytruda Qlexkeytruda-qlexPembrolizumab And Berahyaluronidase Alfa-Pmphpembrolizumab-and-berahyaluronidase-alfa-pmph19-Sep-25NANAMERCK SHARP & DOHME LLCSubcutaneous Injection395MG/4800UNITS(2.4ML), 790MG/9600UNITS(4.8ML)AnticancerTo Treat Adult And Pediatric (12 Years And Older) Solid Tumor Indications Approved For The Intravenous Formulation Of PembrolizumabNANA1,1152,4373,0903,3213,3343,097NAKeytruda Qlex is a subcutaneous formulation of pembrolizumab with berahyaluronidase alfa, approved across multiple solid tumor types. It delivers the same efficacy as IV Keytruda with a quick under-the-skin injection, reducing clinic time for patients.
Brand NameMoleculeApproval Date NCE Date/Market Exclusivity ExpiryNCE-1 Date/Data Exclusivity ExpiryInnovatorDosage FormStrengthTherapeutic CategoryUsageRevenue ($M)Projected Sales By 2028 ($M)CAGR (%)
LeqembileqembiLecanemab-Irmblecanemab-irmb06-Jan-2306-Jan-3506-Jan-27EISAI INC.Injection500 mg/5 mL (100 mg/mL), 200 mg/2 mL (100 mg/mL)AntialzheimerTo Treat Alzheimer’s Disease2917911,4022,1693,0633,8364,6085,27980.12%Leqembi is a prescription medicine for early-stage Alzheimer’s disease. It’s a monoclonal antibody that helps reduce amyloid plaques in the brain and is the first treatment of its kind approved in the European Union.What is Leqembi and how does it work?Leqembi is a monoclonal antibody treatment for early-stage Alzheimer's disease. It works by targeting and reducing amyloid plaques in the brain, potentially helping to slow cognitive decline in patients with mild cognitive impairment or mild dementia.Who is eligible for Leqembi treatment?Leqembi is for patients with early-stage Alzheimer's disease, specifically mild cognitive impairment or mild dementia. Patients must have confirmed elevated beta-amyloid in the brain through testing like PET scans or spinal fluid analysis.How is Leqembi administered?Leqembi is given as an IV infusion every two weeks at a healthcare facility. Each session requires medical supervision and regular monitoring by healthcare professionals.What are the potential side effects and monitoring requirements?
BrenzavvybrenzavvyBexagliflozinbexagliflozin20-Jan-2320-Jan-2820-Jan-27THERACOSBIO LLCTablet20mgAntidiabeticTo Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus As An Adjunct To Diet And ExerciseNA6637648459281,015NANANABrenzavvy is an SGLT2 inhibitor that helps lower your average blood sugar level over 90 to 120 days. It’s FDA-approved to be used alongside diet and exercise to manage blood sugar in adults with type 2 diabetes.
JaypircajaypircaPirtobrutinibpirtobrutinib27-Jan-2327-Jan-2827-Jan-27LOXO ONCOLOGY INCTablet50mg,100mgAnticancerTo Treat Relapsed Or Refractory Mantle Cell Lymphoma In Adults Who Have Had At Least Two Lines Of Systemic Therapy, Including A BTK Inhibitor3376389221,2131,4921,9592,3662,79645.06%Jaypirca is a non-covalent BTK inhibitor used to treat adults with relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia after prior treatments. It’s taken orally once daily.
OrserduorserduElacestrantelacestrant27-Jan-2327-Jan-2827-Jan-27STEMLINE THERAPEUTICS INCTabletEQ 86MG BASE,EQ 345MG BASEHormonal TherapyTo Treat Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated, Advanced Or Metastatic Breast Cancer With Disease Progression Following At Least One Line Of Endocrine TherapyNA6285898139174212NAOrserdu is a once-daily selective estrogen receptor degrader (SERD) approved for ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer in adults after endocrine therapy.
JesduvroqjesduvroqDaprodustatdaprodustat01-Feb-2301-Feb-2801-Feb-27GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLANDTablet1mg,2mg,4mg,6mg,8mgAntianemicTo Treat Anemia Caused By Chronic Kidney Disease For Adults On Dialysis For At Least Four MonthsNA75107134157174185192NAJesduvroq is an oral HIF-PHI approved for the treatment of anemia in adults with chronic kidney disease on dialysis. It was voluntarily withdrawn in the U.S. for non-safety-related reasons but remains FDA-listed.

***Last Updated : 2025-Sep-08 15:00:00

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