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 6 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 14 Sep | Bexlutry | Lutetium Lu 177 Donatate | Curium | NDA Type 5 - New Formulation or New Manufacturer |
| 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 | Omcazio | Cabozantinib Laurylsulfate | Handa Oncol | NDA |
| 3 Sep | Zanvastro New P | Zilganersen Sodium | Ionis Pharms INC | NDA Type 1 - New Molecular Entity |
August 2026 12 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 28 Aug | Mimrylo New P | Rusfertide Acetate | Takeda | NDA Type 1 - New Molecular Entity |
| 27 Aug | Bixlenvo Sunlenca Starter Pack (copackaged) | Bictegravir Sodium, Lenacapavir Sodium | Gilead Sciences | NDA Type 4 - New Combination |
| 27 Aug | Bixlenvo P | Bictegravir Sodium | Gilead Sciences | NDA Type 4 - New Combination |
| 27 Aug | Lisraya New P | Brepocitinib Tosylate | Priovant Therap | NDA Type 1 - New Molecular Entity |
| 26 Aug | Vobrig | Leuprolide Acetate | Sun Pharm | NDA Type 5 - New Formulation or New Manufacturer |
| 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 |
| 14 Aug | Sodium Bicarbonate | Sodium Bicarbonate | Baxter Hlthcare Corp | NDA Type 5 - New Formulation or New Manufacturer |
| 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 |
| 9 Aug | Nitrous Oxide, Usp | Nitrous Oxide | Linde Gas Equip | NDA |
| 5 Aug | Orzeyful New P | Oveporexton | Takeda | NDA Type 1 - New Molecular Entity |
July 2026 16 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 31 Jul | Zimrixby | Rituximab-cdxx | Dr Reddys Labs SA | BLA |
| 29 Jul | Glycophos | Sodium Glycerophosphate | Fresenius Kabi USA | NDA Type 2 - New Active Ingredient |
| 29 Jul | Qlonilik | Clonidine Hydrochloride | Cmp Dev LLC | NDA Type 5 - New Formulation or New Manufacturer |
| 28 Jul | Gwyn Lo | Ethinyl Estradiol Progestin [EPC] |
Viatris Specialty | NDA Type 5 - New Formulation or New Manufacturer |
| 24 Jul | Tylenol With Naproxen | Acetaminophen | Kenvue Brands | NDA Type 4 - New Combination |
| 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 |
| 24 Jul | Garzulys | Insulin Aspart-fsan Insulin Analog [EPC] |
Emerge Bioscience Pte. Ltd. | BLA |
| 22 Jul | Jideytro New | Zidesamtinib | Nuvalent | NDA Type 1 - New Molecular Entity |
| 19 Jul | Air | Air | Noble Gas Solutions Inc. | NDA |
| 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 |
| 10 Jul | Zyogreen | Indocyanine Green Diagnostic Dye [EPC] |
Provepharm Sas | NDA Type 3 - New Dosage Form |
| 9 Jul | Sodium Bicarbonate | Sodium Bicarbonate | Amneal | NDA Type 5 - New Formulation or New Manufacturer |
| 9 Jul | Sarclisa Escena | Isatuximab-irfc CD38-directed Cytolytic Antibody [EPC] |
Sanofi | BLA Type 3 - New Dosage Form |
| 7 Jul | Trutakna New P | Atacicept-vymj | Vera Therapeutics Inc. | BLA Type 1 - New Molecular Entity |
June 2026 7 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 26 Jun | Lumvoa New P | Veligrotug-vvze | Viridian Therapeutics INC | BLA Type 1 - New Molecular Entity |
| 24 Jun | Navitrux | Fosaprepitant Dimeglumine | Avyxa Holdings | NDA Type 5 - New Formulation or New Manufacturer |
| 17 Jun | Utebzi New P | Tebipenem Pivoxil Hydrobromide | GSK | NDA Type 1 - New Molecular Entity |
| 16 Jun | Aprepitant | Aprepitant | Azurity | NDA Type 5 - New Formulation or New Manufacturer |
| 12 Jun | Ambelvist New | Gadoquatrane | Bayer | NDA Type 1 - New Molecular Entity |
| 2 Jun | Tiocystin | Tiopronin | Casper Pharma LLC | NDA Type 5 - New Formulation or New Manufacturer |
| 2 Jun | Ranluspec | Ranibizumab-hkdz | Lupin Limited | BLA Type 2 - New Active Ingredient |
May 2026 15 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 29 May | Xocova New | Ensitrelvir | Shionogi | NDA Type 1 - New Molecular Entity |
| 29 May | Cavhanza | Nilotinib Kinase Inhibitor [EPC] |
Cycle | NDA Type 5 - New Formulation or New Manufacturer |
| 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 | Differin Epiduo Acne Gel (adapalene And Benzoyl Peroxide) | Adapalene, Benzoyl Peroxide Retinoid [EPC] |
Galderma Labs LP | NDA Type 8 - Partial Rx to OTC Switch |
| 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 |
| 15 May | Immgolis | Golimumab-sldi | Accord Biopharma Inc. | BLA Type 5 - New Formulation or New Manufacturer |
| 14 May | Trimbow | Beclomethasone Dipropionate | Chiesi | NDA Type 4 - New Combination |
| 13 May | Beqalzi New P | Sonrotoclax | Beone Medicines USA | NDA Type 1 - New Molecular Entity |
| 7 May | Ennumo | Pegfilgrastim-pccg | Accord Biopharma Inc. | BLA |
| 1 May | Veppanu New | Vepdegestrant | Rigel Pharms | NDA Type 1 - New Molecular Entity |
| 1 May | Evdi | Trabectedin Alkylating Drug [EPC] |
Apotex | NDA Type 5 - New Formulation or New Manufacturer |
| 1 May | Jakafi Xr | Ruxolitinib Phosphate Kinase Inhibitor [EPC] |
Incyte Corp | NDA Type 5 - New Formulation or New Manufacturer |
April 2026 4 approvals
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 29 Apr | Langlara | Insulin Glargine-aldy | Sunshine Lake Pharma Co LTD | BLA |
| 24 Apr | Saphnelo | Anifrolumab-fnia Type I Interferon Receptor Antagonist [EPC] |
AstraZeneca | BLA Type 5 - New Formulation or New Manufacturer |
| 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 |
March 2026 1 approval
| Date | Drug | Active ingredient | Sponsor | Type |
|---|---|---|---|---|
| 30 Mar | Epinephrine | Epinephrine alpha-Adrenergic Agonist [EPC] |
Baxter Hlthcare Corp | NDA New Combination and New Formulation or New Manufacturer |
Source: openFDA (Drugs@FDA). Updated 1h ago. openFDA data is not validated for clinical use — check the FDA label before relying on it.