Joenja-Leniolisib
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.
Zynyz-Retifanlimab-Dlwr
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 […]
Rezzayo-Rezafungin Acetate
Rezzayo 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.
Brenzavvy-Bexagliflozin
Brenzavvy 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.
Jaypirca-Pirtobrutinib
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.
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 It was voluntarily withdrawn in the U.S. for non-safety-related reasons but remains FDA-listed.
Lamzede-Velmanase Alfa-Tycv
Lamzede 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.
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.
