Orserdu-Elacestrant
Orserdu 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.
Jesduvroq-Daprodustat
Jesduvroq 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 It was voluntarily withdrawn in the U.S. for non-safety-related reasons but remains FDA-listed.
Filspari-Sparsentan
Filspari is an oral dual endothelin and angiotensin receptor blocker approved to reduce proteinuria and slow kidney function decline in adults with IgA nephropathy.
Daybue-Trofinetide
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.
Skyclarys-Omaveloxolone
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.
Zavzpret-Zavegepant
Zavzpret 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.
Sohonos-Palovarotene
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.
Aphexda-Motixafortide
Aphexda, 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.
Ojjaara-Momelotinib
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.
Exxua-Gepirone
Exxua 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.
