Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 12 new drug or biologic applications and 14 efficacy supplements (new uses for approved drugs) in August 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 12
Aug 5: the FDA approved Orzeyful (oveporexton), Takeda Pharms Usa, NDA220860 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 9: the FDA approved Nitrous Oxide, Usp (nitrous oxide), Linde Gas Equip, NDA221892 ORIG-1. FDA letter.
Aug 13: the FDA approved Tauklarify (florquinitau f-18), Cerveau Lantheus, NDA220496 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 13: the FDA approved Zenbexus (iberdomide), Bristol Myers Squibb, NDA221075 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 14: the FDA approved Sodium Bicarbonate, Baxter Hlthcare Corp, NDA218524 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Aug 19: the FDA approved Pasatru (garetosmab-grts), Regeneron Pharmaceuticals, Inc, BLA761508 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 26: the FDA approved Rasonque (daraxonrasib), Revolution Medicines, NDA220910 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 26: the FDA approved Vobrig (leuprolide acetate), Sun Pharm, NDA213225 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Aug 27: the FDA approved Bixlenvo (bictegravir/lenacapavir), Gilead Sciences Inc, NDA221104 ORIG-1 (Type 4 - New Combination). FDA letter.
Aug 27: the FDA approved Bixlenvo Sunlenca Starter Pack (bictegravir/lenacapavir, lenacapavir sodium), Gilead Sciences Inc, NDA221443 ORIG-1 (Type 4 - New Combination). FDA letter.
Aug 27: the FDA approved Lisraya (brepocitinib), Priovant Therap, NDA220106 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 28: the FDA approved Mimrylo (rusfertide), Takeda Pharms Am, NDA220605 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
New uses for approved drugs (efficacy supplements) · 14
Aug 14: the FDA approved an efficacy supplement for Yesintek (ustekinumab-kfce), Biocon Biologics Inc, BLA761406 SUPPL-2. FDA letter.
Aug 20: the FDA approved an efficacy supplement for Empaveli (pegcetacoplan), Apellis Pharms, NDA215014 SUPPL-12. FDA letter.
Aug 24: the FDA approved an efficacy supplement for Imaavy (nipocalimab-aahu), Janssen Biotech, BLA761430 SUPPL-2. FDA letter.
Aug 25: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-18. FDA letter.
Aug 25: the FDA approved an efficacy supplement for Tivicay (dolutegravir sodium), Viiv Hlthcare, NDA204790 SUPPL-34. FDA letter.
Aug 25: the FDA approved an efficacy supplement for Tivicay Pd (dolutegravir sodium), Viiv Hlthcare, NDA213983 SUPPL-7. FDA letter.
Aug 25: the FDA approved an efficacy supplement for Ziihera (zanidatamab-hrii), Jazz Pharms, BLA761416 SUPPL-2. FDA letter.
Aug 26: the FDA approved an efficacy supplement for Zepbound (tirzepatide), Eli Lilly And Co, NDA217806 SUPPL-41. FDA letter.
Aug 27: the FDA approved an efficacy supplement for Mounjaro (tirzepatide), Eli Lilly And Co, NDA215866 SUPPL-44. FDA letter.
Aug 27: the FDA approved an efficacy supplement for Mounjaro (tirzepatide), Eli Lilly And Co, NDA215866 SUPPL-45. FDA letter.
Aug 27: the FDA approved an efficacy supplement for Sunlenca (lenacapavir sodium), Gilead Sciences Inc, NDA215973 SUPPL-24. FDA letter.
Aug 27: the FDA approved an efficacy supplement for Sunlenca (lenacapavir sodium), Gilead Sciences Inc, NDA215974 SUPPL-17. FDA letter.
Aug 28: the FDA approved an efficacy supplement for Besremi (ropeginterferon alfa-2b), Pharmaessentia Corp, BLA761166 SUPPL-13. FDA letter.
Aug 28: the FDA approved an efficacy supplement for Ustekinumab, Janssen Biotech, BLA761044 SUPPL-21. FDA letter.