The FDA approved an average of 47 new drugs annually from 2015 to 2024.
A few notables.
Ekterly (sebetralstat) – Treats hereditary angioedema (approved July 3, 2025)
Zegfrovy (sunvozertinib) – For NSCLC with EGFR exon-20 insertion mutations (July 2, 2025)
Widaplik (amlodipine + indapamide + telmisartan) – Single-pill hypertension therapy (June 5, 2025)
Tryptyr (acoltremon ophthalmic) – First in class dry-eye treatment (May 28, 2025)
mNEXSPIKE – Next-gen Moderna mRNA COVID-19 vaccine (May 30, 2025)
Emrelis (telisotuzumab vedotin) – Lung cancer (NSCLC) targeted therapy (May 14, 2025)
Yutrepia (treprostinil inhalation) – For pulmonary arterial hypertension (May 23, 2025)
Brekiya (dihydroergotamine autoinjector) – Acute migraine and cluster headache therapy (May 14, 2025)
Gomekli, Journavx, Grafapex, Datroway – Novel agents in oncology and pain management (early 2025)
Opzelura (ruxolitinib cream) – For vitiligo and atopic dermatitis (2022–2023)
Cobenfy (KarXT) – New schizophrenia medication targeting cholinergic receptors (Sept 2024)
Tarlatamab (Imdelltra) – First in class BiTE immunotherapy for small-cell lung cancer (May 2024)
Pegcetacoplan (Empaveli/Syfovre) – First complement C3 inhibitor for PNH & geographic atrophy (May 2021)
Leniolisib (Joenja) – First treatment for APDS immune deficiency (March 2023)
Nedosiran (Rivfloza) – siRNA therapy for primary hyperoxaluria (Sept 2023)
Retifanlimab (Zynyz) – PD-1 antibody for Merkel cell carcinoma (March 2023)
Are you aware of any of these?