Itovebi-Inavolisib
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.
Hympavzi-Marstacimab-Hncq
Hympavzi 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.
Voranigo-Vorasidenib
Voranigo 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
Nemluvio-Nemolizumab-Ilto
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.
Anktiva-Nogapendekin Alfa Inbakicept-Pmln
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.
Yorvipath-Palopegteriparatide
Yorvipath is used to treat hypoparathyroidism. It is a ready-to-use injection that is administered once a day to people with hypoparathyroidism.
Ojemda-Tovorafenib
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.
Xolremdi-Mavorixafor
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.
Imdelltra-Tarlatamab-Dlle
Imdelltra is used to treat adults with extensive-stage small cell lung cancer (ES-SCLC) that has returned after platinum-based chemotherapy.
Rytelo-Imetelstat
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).
