Tracker
FDA drug approvals
Original FDA approvals of new drug applications (NDA) and biologics (BLA) over the last six months. New marks a new molecular entity or novel biologic; P a priority review.
September 2026 4 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 11 Sep | Pixclara New P | Floretyrosine F 18 | Telix Pharmaceuticals US INC | NDA Type 1 - New Molecular Entity |
| 11 Sep | Isembyld New P | Apitegromab-mstn | Scholar Rock INC | BLA Type 1 - New Molecular Entity |
| 4 Sep | Etcamah New | Camizestrant | AstraZeneca | NDA Type 1 - New Molecular Entity |
| 3 Sep | Zanvastro New P | Zilganersen Sodium | Ionis Pharms INC | NDA Type 1 - New Molecular Entity |
August 2026 7 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 28 Aug | Mimrylo New P | Rusfertide Acetate | Takeda | NDA Type 1 - New Molecular Entity |
| 27 Aug | Lisraya New P | Brepocitinib Tosylate | Priovant Therap | NDA Type 1 - New Molecular Entity |
| 26 Aug | Rasonque New P | Daraxonrasib | Revolution Medicines | NDA Type 1 - New Molecular Entity |
| 19 Aug | Pasatru New P | Garetosmab-grts | Regeneron | BLA Type 1 - New Molecular Entity |
| 13 Aug | Tauklarify New | Florquinitau F-18 | Cerveau Lantheus | NDA Type 1 - New Molecular Entity |
| 13 Aug | Zenbexus New P | Iberdomide Hydrochloride | Bristol Myers Squibb | NDA Type 1 - New Molecular Entity |
| 5 Aug | Orzeyful New P | Oveporexton | Takeda | NDA Type 1 - New Molecular Entity |
July 2026 6 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 24 Jul | Simtriyo New P | Centanafadine Hydrochloride | Otsuka Pharmaceutical Co LTD | NDA Type 1 - New Molecular Entity |
| 24 Jul | Lytenava New | Bevacizumab-vikg | Outlook Therapeutics, Inc. | BLA Type 1 - New Molecular Entity and Type 4 - New Combination |
| 22 Jul | Jideytro New | Zidesamtinib | Nuvalent | NDA Type 1 - New Molecular Entity |
| 15 Jul | Lipfendra New P | Enlicitide Decanoate | Msd | NDA Type 1 - New Molecular Entity |
| 14 Jul | Revtorpyk New P | Gedatolisib | Celcuity | NDA Type 1 - New Molecular Entity |
| 7 Jul | Trutakna New P | Atacicept-vymj | Vera Therapeutics Inc. | BLA Type 1 - New Molecular Entity |
June 2026 3 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 26 Jun | Lumvoa New P | Veligrotug-vvze | Viridian Therapeutics INC | BLA Type 1 - New Molecular Entity |
| 17 Jun | Utebzi New P | Tebipenem Pivoxil Hydrobromide | GSK | NDA Type 1 - New Molecular Entity |
| 12 Jun | Ambelvist New | Gadoquatrane | Bayer | NDA Type 1 - New Molecular Entity |
May 2026 8 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 29 May | Xocova New | Ensitrelvir | Shionogi | NDA Type 1 - New Molecular Entity |
| 29 May | Cypsedo New | Cipepofol | Haisco | NDA Type 1 - New Molecular Entity |
| 29 May | Zaynich New P | Cefepime Hydrochloride | Wockhardt Bio AG | NDA Type 1 - New Molecular Entity and Type 4 - New Combination |
| 27 May | Decnupaz New P | Pivekimab Sunirine-pvzy | AbbVie | BLA Type 1 - New Molecular Entity |
| 22 May | Hepcludex New P | Bulevirtide-gmod | Gilead Sciences | BLA Type 1 - New Molecular Entity |
| 15 May | Baxfendy New P | Baxdrostat | AstraZeneca | NDA Type 1 - New Molecular Entity |
| 13 May | Beqalzi New P | Sonrotoclax | Beone Medicines USA | NDA Type 1 - New Molecular Entity |
| 1 May | Veppanu New | Vepdegestrant | Rigel Pharms | NDA Type 1 - New Molecular Entity |
April 2026 2 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 20 Apr | Idvynso New | Doravirine Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
Msd | NDA Type 1 - New Molecular Entity and Type 4 - New Combination |
| 1 Apr | Foundayo New | Orforglipron Calcium | Eli Lilly | NDA Type 1 - New Molecular Entity |
Source: openFDA (Drugs@FDA). Updated 25m ago. openFDA data is not validated for clinical use — check the FDA label before relying on it.