Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 15 new drug or biologic applications and 21 efficacy supplements (new uses for approved drugs) in May 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 15
May 1: the FDA approved Evdi (trabectedin), Apotex, NDA220837 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
May 1: the FDA approved Jakafi Xr (ruxolitinib), Incyte Corp, NDA217180 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
May 1: the FDA approved Veppanu (vepdegestrant), Rigel Pharms, NDA219835 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 7: the FDA approved Ennumo (pegfilgrastim-pccg), Accord Biopharma Inc., BLA761147 ORIG-1. FDA letter.
May 13: the FDA approved Beqalzi (sonrotoclax), Beone Medicines Usa, NDA220711 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 14: the FDA approved Trimbow (beclomethasone dipropionate, formoterol fumarate, glycopyrrolate), Chiesi, NDA219622 ORIG-1 (Type 4 - New Combination). FDA letter.
May 15: the FDA approved Baxfendy (baxdrostat), Astrazeneca Ab, NDA219878 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 15: the FDA approved Immgolis (golimumab-sldi), Accord Biopharma Inc., BLA761452 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
May 22: the FDA approved Differin Epiduo (adapalene and benzoyl peroxide), Galderma Labs Lp, NDA220736 ORIG-1 (Type 8 - Partial Rx to OTC Switch). FDA letter.
May 22: the FDA approved Hepcludex (bulevirtide), Gilead Sciences Inc, BLA761468 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 27: the FDA approved Decnupaz (pivekimab sunirine-pvzy), Abbvie Inc, BLA761460 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 29: the FDA approved Cavhanza (nilotinib), Cycle, NDA217379 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
May 29: the FDA approved Cypsedo (cipepofol), Haisco, NDA220482 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 29: the FDA approved Xocova (ensitrelvir), Shionogi, NDA220442 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 29: the FDA approved Zaynich (zidebactam dihydrate and cefepime hydrochloride), Wockhardt Bio Ag, NDA220787 ORIG-1 (Type 1 - New Molecular Entity and Type 4 - New Combination). FDA letter.
New uses for approved drugs (efficacy supplements) · 21
May 8: the FDA approved an efficacy supplement for Bizengri (zenocutuzumab), Merus N.V., BLA761352 SUPPL-10. FDA letter.
May 8: the FDA approved an efficacy supplement for Ocrevus (ocrelizumab), Genentech Inc, BLA761053 SUPPL-38. FDA letter.
May 8: the FDA approved an efficacy supplement for Vyvgart (efgartigimod alfa), Argenx Bv, BLA761195 SUPPL-16. FDA letter.
May 8: the FDA approved an efficacy supplement for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)), Argenx Bv, BLA761304 SUPPL-18. FDA letter.
May 12: the FDA approved an efficacy supplement for Zerbaxa (ceftolozane and tazobactam), Cubist Pharms Llc, NDA206829 SUPPL-23. FDA letter.
May 13: the FDA approved an efficacy supplement for Fasenra (benralizumab), Astrazeneca Ab, BLA761070 SUPPL-23. FDA letter.
May 13: the FDA approved an efficacy supplement for Inqovi (cedazuridine and decitabine), Taiho Oncology, NDA212576 SUPPL-8. FDA letter.
May 13: the FDA approved an efficacy supplement for Nuzyra (omadacycline), Paratek Pharms, NDA209817 SUPPL-18. FDA letter.
May 13: the FDA approved an efficacy supplement for Nuzyra (omadacycline), Paratek Pharms, NDA209816 SUPPL-18. FDA letter.
May 15: the FDA approved an efficacy supplement for Enhertu (fam-trastuzumab deruxtecan-nxki), Daiichi Sankyo, BLA761139 SUPPL-43. FDA letter.
May 15: the FDA approved an efficacy supplement for Enhertu (fam-trastuzumab deruxtecan-nxki), Daiichi Sankyo, BLA761139 SUPPL-41. FDA letter.
May 15: the FDA approved an efficacy supplement for Tecentriq (atezolizumab), Genentech Inc, BLA761034 SUPPL-61. FDA letter.
May 15: the FDA approved an efficacy supplement for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), Genentech Inc, BLA761347 SUPPL-8.
May 18: the FDA approved an efficacy supplement for Zynyz (retifanlimab-dlwr), Incyte Corp, BLA761334 SUPPL-9. FDA letter.
May 20: the FDA approved an efficacy supplement for Venclexta (venetoclax), Abbvie, NDA208573 SUPPL-32. FDA letter.
May 21: the FDA approved an efficacy supplement for Linzess (linaclotide), Abbvie, NDA202811 SUPPL-23. FDA letter.
May 22: the FDA approved an efficacy supplement for Datroway (datopotamab deruxtecan), Daiichi Sankyo Inc, BLA761394 SUPPL-3. FDA letter.
May 23: the FDA approved an efficacy supplement for Uptravi (selexipag), Actelion, NDA207947 SUPPL-14. FDA letter.
May 28: the FDA approved an efficacy supplement for Imfinzi (durvalumab), Astrazeneca Uk Ltd, BLA761069 SUPPL-53. FDA letter.
May 28: the FDA approved an efficacy supplement for Tremfya (guselkumab), Janssen Biotech, BLA761061 SUPPL-34. FDA letter.
May 29: the FDA approved an efficacy supplement for Afrezza (insulin human), Mannkind, BLA022472 SUPPL-29. 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. ← April 2026 · June 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026