FDA approvals, November 2025

The FDA approved 8 new drug or biologic applications and 23 efficacy supplements (new uses for approved drugs) in November 2025, per Drugs@FDA as read on 2026-11-12.

New drug and biologic applications · 8

• Nov 3: the FDA approved Kygevvi (doxecitine and doxribtimine), Ucb Inc, NDA219792 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Nov 13: the FDA approved Komzifti (ziftomenib), Kura, NDA220305 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Nov 13: the FDA approved Poherdy (pertuzumab-dpzb), Shanghai Henlius Biotech, BLA761450 ORIG-1. FDA letter.
• Nov 18: the FDA approved Redemplo (plozasiran), Arrowhead, NDA219947 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Nov 19: the FDA approved Hyrnuo (sevabertinib), Bayer Healthcare, NDA219972 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Nov 25: the FDA approved Voyxact (sibeprenlimab), Otsuka Pharm Co Ltd, BLA761434 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Nov 28: the FDA approved Armlupeg (pegfilgrastim-unne), Lupin Ltd, BLA761212 ORIG-1. FDA letter.
• Nov 28: the FDA approved Epysqli (eculizumab-aagh), Samsung Bioepis Co Ltd, BLA761340 ORIG-2 (Efficacy). FDA letter.

New uses for approved drugs (efficacy supplements) · 23

• Nov 4: the FDA approved an efficacy supplement for Linzess (linaclotide), Abbvie, NDA202811 SUPPL-22. FDA letter.
• Nov 5: the FDA approved an efficacy supplement for Caplyta (lumateperone), Intra-Cellular, NDA209500 SUPPL-16. FDA letter.
• Nov 6: the FDA approved an efficacy supplement for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)), Janssen Biotech, BLA761145 SUPPL-29. FDA letter.
• Nov 18: the FDA approved an efficacy supplement for Epkinly (epcoritamab-bysp), Genmab Us, Inc., BLA761324 SUPPL-9. FDA letter.
• Nov 19: the FDA approved an efficacy supplement for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)), Janssen Biotech, BLA761145 SUPPL-32. FDA letter.
• Nov 19: the FDA approved an efficacy supplement for Eylea Hd (aflibercept), Regeneron Pharmaceuticals, BLA761355 SUPPL-10. FDA letter.
• Nov 19: the FDA approved an efficacy supplement for Igalmi (dexmedetomidine hydrochloride), Bioxcel, NDA215390 SUPPL-2. FDA letter.
• Nov 19: the FDA approved an efficacy supplement for Imdelltra (Amg757) (tarlatamab-dlle), Amgen Inc, BLA761344 SUPPL-1. FDA letter.
• Nov 19: the FDA approved an efficacy supplement for Koselugo (selumetinib), Astrazeneca, NDA213756 SUPPL-6. FDA letter.
• Nov 20: the FDA approved an efficacy supplement for Retevmo (selpercatinib), Eli Lilly And Co, NDA218160 SUPPL-6. FDA letter.
• Nov 20: the FDA approved an efficacy supplement for Retevmo (selpercatinib), Eli Lilly And Co, NDA213246 SUPPL-15. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-188. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 SUPPL-1. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Livtencity (maribavir), Takeda Pharms Usa, NDA215596 SUPPL-7. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Nexletol (bempedoic acid), Esperion Theraps Inc, NDA211616 SUPPL-24. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Nexlizet (bempedoic acid and ezetimibe), Esperion Theraps Inc, NDA211617 SUPPL-29. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Padcev Ejfv (enfortumab vedotin), Astellas, BLA761137 SUPPL-32. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Unloxcyt (cosibelimab), Checkpoint Therapeutics Inc, BLA761297 SUPPL-1. FDA letter.
• Nov 21: the FDA approved an efficacy supplement for Wegovy (semaglutide), Novo, NDA215256 SUPPL-23. FDA letter.
• Nov 24: the FDA approved an efficacy supplement for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), Bristol-Myers Squibb, BLA761381 SUPPL-5. FDA letter.
• Nov 24: the FDA approved an efficacy supplement for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), Genentech Inc, BLA761347 SUPPL-4. FDA letter.
• Nov 25: the FDA approved an efficacy supplement for Imfinzi (durvalumab), Astrazeneca Uk Ltd, BLA761069 SUPPL-52. FDA letter.
• Nov 25: the FDA approved an efficacy supplement for Scemblix (asciminib), Novartis, NDA215358 SUPPL-12. FDA letter.

Source: openFDA drugsfda (the Drugs@FDA data), read 2026-11-12. openFDA trails Drugs@FDA by about a week, so the latest days of a month can be missing until the next read. Generic approvals (ANDAs), labeling-only and manufacturing supplements are not listed. ← October 2025 · December 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025