Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 17 new drug or biologic applications and 25 efficacy supplements (new uses for approved drugs) in December 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 17
Dec 11: the FDA approved Daybue Stix (trofinetide), Acadia Pharms Inc, NDA219884 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Dec 11: the FDA approved Orladeyo (berotralstat hydrochloride), Biocryst, NDA219776 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Dec 12: the FDA approved Cardamyst (etripamil), Milestone Pharms Usa, NDA218571 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Dec 12: the FDA approved Lerochol (lerodalcibep-liga), Lib Therapeutics, Inc., BLA761427 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Dec 12: the FDA approved Nuzolvence (zoliflodacin), Entasis Therap, NDA219491 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Dec 16: the FDA approved Exdensur (depemokimab), Glaxosmithkline Llc, BLA761458 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Dec 16: the FDA approved Vybrique (sildenafil citrate), Ibsa, NDA210858 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Dec 17: the FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)), Janssen Biotech, BLA761433 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Dec 18: the FDA approved Nufymco (ranibizumab-leyk), Formycon Ag, BLA761473 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
Dec 19: the FDA approved Boncresa (denosumab-mobz), Amneal Pharms Llc, BLA761456 ORIG-1. FDA letter.
Dec 19: the FDA approved Jascayd (nerandomilast), Boehringer Ingelheim, NDA220449 ORIG-1 (Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval). FDA letter.
Dec 19: the FDA approved Myqorzo (aficamten), Cytokinetics, NDA219083 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Dec 19: the FDA approved Oziltus (denosumab-mobz), Amneal Pharms Llc, BLA761457 ORIG-1. FDA letter.
Dec 22: the FDA approved Mucinex 12Hr Cold And Fever Multi-Symptom (naproxen sodium, dextromethorphan hydrobromide, guaifenesin), Reckitt Benckiser, NDA217338 ORIG-1 (Type 4 - New Combination). FDA letter.
Dec 22: the FDA approved Wegovy (semaglutide), Novo, NDA218316 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Dec 23: the FDA approved Yartemlea (narsoplimab), Omeros Corp, BLA761152 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Dec 30: the FDA approved Nereus (tradipitant), Vanda Pharms Inc, NDA220152 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
New uses for approved drugs (efficacy supplements) · 25
Dec 2: the FDA approved an efficacy supplement for Jaypirca (pirtobrutinib), Loxo Oncol, NDA216059 SUPPL-5. FDA letter.
Dec 9: the FDA approved an efficacy supplement for Recarbrio (imipenem anhydrous, cilastatin, and relebactam anhydrous), Msd Merck Co, NDA212819 SUPPL-8. FDA letter.
Dec 9: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-10. FDA letter.
Dec 9: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-9. FDA letter.
Dec 9: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-13. FDA letter.
Dec 11: the FDA approved an efficacy supplement for Blujepa (gepotidacin), Glaxosmithkline, NDA218230 SUPPL-1. FDA letter.
Dec 11: the FDA approved an efficacy supplement for Uplizna (inebilizumab), Viela Bio, BLA761142 SUPPL-4. FDA letter.
Dec 12: the FDA approved an efficacy supplement for Akeega (niraparib tosylate monohydrate and abiraterone acetate), Janssen Biotech, NDA216793 SUPPL-1. FDA letter.
Dec 12: the FDA approved an efficacy supplement for Ilumya (tildrakizumab-asmn), Sun Pharma Global, BLA761067 SUPPL-24. FDA letter.
Dec 13: the FDA approved an efficacy supplement for Addyi (flibanserin), Sprout Pharms, NDA022526 SUPPL-13. FDA letter.
Dec 15: the FDA approved an efficacy supplement for Enhertu (fam-trastuzumab deruxtecan-nxki), Daiichi Sankyo, BLA761139 SUPPL-38. FDA letter.
Dec 17: the FDA approved an efficacy supplement for Rubraca (rucaparib), Pharmaand, NDA209115 SUPPL-15. FDA letter.
Dec 17: the FDA approved an efficacy supplement for Rubraca (rucaparib), Pharmaand, NDA209115 SUPPL-14. FDA letter.
Dec 17: the FDA approved an efficacy supplement for Zynyz (retifanlimab-dlwr), Incyte Corp, BLA761334 SUPPL-5. FDA letter.
Dec 18: the FDA approved an efficacy supplement for Vraylar (cariprazine), Abbvie, NDA204370 SUPPL-17. FDA letter.
Dec 18: the FDA approved an efficacy supplement for Vraylar (cariprazine), Abbvie, NDA204370 SUPPL-15. FDA letter.
Dec 18: the FDA approved an efficacy supplement for Vraylar (cariprazine), Abbvie, NDA204370 SUPPL-16. FDA letter.
Dec 18: the FDA approved an efficacy supplement for Vraylar (cariprazine), Abbvie, NDA204370 SUPPL-14. FDA letter.
Dec 19: the FDA approved an efficacy supplement for Accrufer (ferric maltol), Shield Tx, NDA212320 SUPPL-19. FDA letter.
Dec 19: the FDA approved an efficacy supplement for Bylvay (odevixibat), Ipsen, NDA215498 SUPPL-5. FDA letter.
Dec 19: the FDA approved an efficacy supplement for Lunsumio (mosunetuzumab), Genentech Inc, BLA761263 SUPPL-6. FDA letter.
Dec 19: the FDA approved an efficacy supplement for Mounjaro (tirzepatide), Eli Lilly And Co, NDA215866 SUPPL-39. FDA letter.
Dec 22: the FDA approved an efficacy supplement for Furoscix (furosemide injection 80 mg/ 10 ml), Scpharmaceuticals, NDA209988 SUPPL-4. FDA letter.
Dec 23: the FDA approved an efficacy supplement for Aqvesme (mitapivat), Agios Pharms Inc, NDA216196 SUPPL-3. FDA letter.
Dec 23: the FDA approved an efficacy supplement for Cablivi (caplacizumab), Ablynx Nv, BLA761112 SUPPL-18. FDA letter.