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The FDA approved 4 new drug or biologic applications and 22 efficacy supplements (new uses for approved drugs) in April 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 4
Apr 1: the FDA approved Foundayo (orforglipron), Eli Lilly And Co, NDA220934 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Apr 20: the FDA approved Idvynso (doravirine, islatravir), Msd, NDA216964 ORIG-1 (Type 1 - New Molecular Entity and Type 4 - New Combination). FDA letter.
Apr 24: the FDA approved Saphnelo (anifrolumab-fnia), Astrazeneca Ab, BLA761451 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Apr 29: the FDA approved Insulin Glargine-Aldy, Sunshine Lake Pharma Co Ltd, BLA761412 ORIG-1. FDA letter.
New uses for approved drugs (efficacy supplements) · 22
Apr 2: the FDA approved an efficacy supplement for Eylea Hd (aflibercept), Regeneron Pharmaceuticals, BLA761355 SUPPL-5. FDA letter.
Apr 9: the FDA approved an efficacy supplement for Onureg (azacitidine), Bristol, NDA214120 SUPPL-3. FDA letter.
Apr 9: the FDA approved an efficacy supplement for Vabysmo (faricimab), Genentech Inc, BLA761235 SUPPL-8. FDA letter.
Apr 13: the FDA approved an efficacy supplement for Filspari (sparsentan), Travere, NDA216403 SUPPL-6. FDA letter.
Apr 15: the FDA approved an efficacy supplement for Itovebi (inavolisib), Genentech Inc, NDA219249 SUPPL-4. FDA letter.
Apr 15: the FDA approved an efficacy supplement for Ustekinumab, Janssen Biotech, BLA761044 SUPPL-20. FDA letter.
Apr 15: the FDA approved an efficacy supplement for Wainua (eplontersen), Astrazeneca Ab, NDA217388 SUPPL-5. FDA letter.
Apr 17: the FDA approved an efficacy supplement for Cosentyx (secukinumab), Novartis Pharms Corp, BLA125504 SUPPL-97. FDA letter.
Apr 17: the FDA approved an efficacy supplement for Cosentyx (secukinumab), Novartis Pharms Corp, BLA125504 SUPPL-98. FDA letter.
Apr 20: the FDA approved an efficacy supplement for Tzield (teplizumab-mzwv), Provention Bio Inc, BLA761183 SUPPL-13. FDA letter.
Apr 22: the FDA approved an efficacy supplement for Dupixent (dupilumab), Regeneron Pharmaceuticals, BLA761055 SUPPL-74. FDA letter.
Apr 23: the FDA approved an efficacy supplement for Crysvita (burosumab), Kyowa Kirin, BLA761068 SUPPL-11. FDA letter.
Apr 23: the FDA approved an efficacy supplement for Perjeta (pertuzumab), Genentech, BLA125409 SUPPL-141. FDA letter.
Apr 23: the FDA approved an efficacy supplement for Xpovio (selinexor), Karyopharm Theraps, NDA212306 SUPPL-18. FDA letter.
Apr 24: the FDA approved an efficacy supplement for Caplyta (lumateperone), Intra-Cellular, NDA209500 SUPPL-17. FDA letter.
Apr 24: the FDA approved an efficacy supplement for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 SUPPL-3. FDA letter.
Apr 27: the FDA approved an efficacy supplement for Breztri Aerosphere (budesonide, formoterol fumarate, glycopyrrolate), Astrazeneca Ab, NDA212122 SUPPL-9. FDA letter.
Apr 27: the FDA approved an efficacy supplement for Enhertu (fam-trastuzumab deruxtecan-nxki), Daiichi Sankyo, BLA761139 SUPPL-39. FDA letter.
Apr 27: the FDA approved an efficacy supplement for Nuplazid (pimavanserin tartrate), Acadia Pharms Inc, NDA210793 SUPPL-14. FDA letter.
Apr 27: the FDA approved an efficacy supplement for Nuplazid (pimavanserin tartrate), Acadia Pharms Inc, NDA207318 SUPPL-16. FDA letter.
Apr 27: the FDA approved an efficacy supplement for Symbicort Aerosphere (budesonide, formoterol fumarate), Astrazeneca, NDA216579 SUPPL-1. FDA letter.
Apr 30: the FDA approved an efficacy supplement for Auvelity (dextromethorphan hydrobromide, bupropion hydrochloride), Axsome, NDA215430 SUPPL-18. 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. ← March 2026 · May 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026