FDA drug approvals recorded by openFDA between 2026-08-30 and 2026-09-13, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha.
| Approval Date | Company | Drug | Ticker |
|---|---|---|---|
| 2026-09-09 | Bayer HealthCare Pharmaceuticals Inc. | HYRNUO | BAYRY |
| 2026-09-09 | Biofrontera Inc. | AMELUZ | n/a |
| 2026-09-08 | HETERO LABS LTD V | IBRUTINIB | n/a |
| 2026-09-08 | Saptalis Pharmaceuticals, LLC. | TRIAMCINOLONE ACETONIDE | n/a |
| 2026-09-08 | ZHEJIANG JUTAI PHARM | BRIVARACETAM | n/a |
| 2026-09-04 | ACTAVIS ELIZABETH | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | n/a |
| 2026-09-04 | AstraZeneca Pharmaceuticals LP | ETCAMAH | AZN |
| 2026-09-04 | Clarity Cosmetics Inc. | MINOXIDIL | n/a |
| 2026-09-04 | MICRO LABS | TOPIRAMATE | AMD |
| 2026-09-04 | NorthStar Rx LLC | NITROFURANTOIN | n/a |
| 2026-09-04 | Tris Pharma Inc | LACOSAMIDE | n/a |
| 2026-09-03 | BPI LABS | TESTOSTERONE CYPIONATE | n/a |
| 2026-09-03 | HANDA ONCOLOGY, LLC | n/a | n/a |
| 2026-09-03 | Horizon Therapeutics USA, Inc. | UPLIZNA | AMGN |
| 2026-09-03 | IONIS PHARMS INC | ZANVASTRO | IONS |
| 2026-09-03 | LUPIN | MODAFINIL | n/a |
| 2026-09-03 | Modavar Pharmaceuticals LLC | ACYCLOVIR | n/a |
| 2026-09-03 | Novadoz Pharmaceuticals LLC | TAPENTADOL HYDROCHLORIDE | n/a |
| 2026-09-02 | Aadi Bioscience, Inc. | FYARRO | n/a |
| 2026-09-02 | Actavis Pharma, Inc. | BUPROPION HYDROCHLORIDE SR | n/a |
| 2026-09-02 | Ajanta Pharma USA Inc. | DAPAGLIFLOZIN | n/a |
| 2026-09-02 | AUROBINDO PHARMA LTD | SACUBITRIL AND VALSARTAN | n/a |
| 2026-09-02 | Celgene Corporation | THALOMID | n/a |
| 2026-09-02 | CELLTRION USA, Inc. | AVTOZMA | n/a |
| 2026-09-02 | H2-Pharma, LLC | ETOPOPHOS | n/a |
| 2026-09-02 | NATCO | THALIDOMIDE | n/a |
| 2026-09-02 | PHARMOBEDIENT | DIVALPROEX SODIUM | n/a |
| 2026-09-02 | PRECISION DOSE INC | ALENDRONATE SODIUM | n/a |
| 2026-09-02 | SUN PHARM INDS LTD | OXCARBAZEPINE | n/a |
| 2026-09-02 | U.S. Pharmaceuticals | CIBINQO | n/a |
| 2026-09-01 | B. Braun Medical Inc. | LIDOCAINE HCL AND EPINEPHRINE | n/a |
| 2026-09-01 | BIOGEN INC. | BYOOVIZ | BIIB |
| 2026-09-01 | Chartwell RX, LLC | ULTRAMICROSIZE GRISEOFULVIN | n/a |
| 2026-09-01 | Leading Pharma, LLC | DOXEPIN HYDROCHLORIDE | n/a |
| 2026-09-01 | Meitheal Pharmaceuticals Inc | NELARABINE | n/a |
| 2026-09-01 | Mirati Therapeutics, Inc | KRAZATI | BMY |
| 2026-09-01 | Mylan Pharmaceuticals Inc. | NEVIRAPINE | VTRS |
| 2026-09-01 | Pharmacia & Upjohn Company LLC | CLEOCIN HYDROCHLORIDE | VTRS |
| 2026-08-31 | Akeso Biopharma, Co., Ltd | PENPULIMAB KCQX | n/a |
| 2026-08-31 | AstraZeneca Pharmaceuticals LP | IMFINZI | AZN |
| 2026-08-31 | AstraZeneca Pharmaceuticals LP | IMJUDO | AZN |
| 2026-08-31 | Aurohealth LLC | FEXOFENADINE HYDROCHLORIDE | n/a |
| 2026-08-31 | Baxter Healthcare Corporation | CEFAZOLIN | BAX |
| 2026-08-31 | Baxter Healthcare Corporation | OXACILLIN | BAX |
| 2026-08-31 | Chattem, Inc. | CHILDRENS XYZAL ALLERGY | n/a |
| 2026-08-31 | Cipla USA Inc. | POMALIDOMIDE | n/a |
| 2026-08-31 | Coherus Oncology, Inc. | LOQTORZI | CHRS |
| 2026-08-31 | Dr. Reddy’s Laboratories Inc. | POMALIDOMIDE | RDY |
| 2026-08-31 | E.R. Squibb & Sons, L.L.C. | YERVOY | BMY |
| 2026-08-31 | EMD Serono, Inc. | BAVENCIO | MKKGY |
| 2026-08-31 | Leading Pharma, LLC | FENOFIBRIC ACID | n/a |
| 2026-08-31 | Lupin Pharmaceuticals, Inc. | MEFENAMIC ACID | n/a |
| 2026-08-31 | MACLEODS PHARMS LTD | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | n/a |
| 2026-08-31 | Micro Labs Limited | MEFENAMIC ACID | AMD |
| 2026-08-31 | Micro Labs Limited | TRANEXAMIC ACID | AMD |
| 2026-08-31 | PETNET Solutions, Inc. | FLUDEOXYGLUCOSE F 18 | n/a |
| 2026-08-31 | QILU PHARM HAINAN | DIFELIKEFALIN ACETATE | n/a |
| 2026-08-31 | Regeneron Pharmaceuticals, Inc. | LIBTAYO | REGN |
| 2026-08-31 | SANDOZ | EPLERENONE | SDZWF |
| 2026-08-31 | SANDOZ | TERIFLUNOMIDE | SDZWF |
| 2026-08-31 | Sandoz Inc | POMALIDOMIDE | SDZWF |
| 2026-08-31 | Sun Pharmaceutical Industries, Inc. | POMALIDOMIDE | n/a |
| 2026-08-31 | Sun Pharmaceutical Industries, Inc. | UNLOXCYT | n/a |
Only the 63 most relevant rows are shown. Approved applications (originals and supplements) in this window: 64; rows shown: 63; tickers identified: 23. Known pharma subsidiaries are mapped to their US-listed parent or ADR (e.g. Janssen -> JNJ, Novartis -> NVS). Companies shown as “n/a” are mostly foreign or privately held drug makers (mostly generics) with no US-listed stock.
Data source: openFDA