Recent FDA Approvals
BETA122
New Drugs 2026
-702 vs 2025
19
NDA (Small Molecule)
14
BLA (Biologics)
7
From Biotechs
New Drug Approvals by Year
868 2022
904 2023
853 2024
824 2025
122 2026
Application Types: NDA New Drug Application (novel small molecule) BLA Biologics License (antibodies, vaccines, gene therapy) ANDA Abbreviated NDA (generic drug)
Period:
Showing 200 of 200 approvals
Type:
Company:
Area:
LOARGYS (PEGZILARGINASE-NBLN)
Type 1 - New Molecular Entity PRIORITY 2026-02-23
BYSANTI (MILSAPERIDONE)
Type 1 - New Molecular Entity 2026-02-20
FAVLYXA (FLUOROURACIL)
Type 5 - New Formulation or New Manufacturer 2026-02-20
AVOPEF (ETOPOSIDE)
Type 3 - New Dosage Form 2026-02-13
RYBREVANT FASPROI (AMIVANTAMAB AND HYALURONIDASE-LPUJ)
Type 5 - New Formulation or New Manufacturer 2026-02-13
ADQUEY (DIFAMILAST)
Type 1 - New Molecular Entity 2026-02-12
VYKOURA (LEUCOVORIN CALCIUM)
Type 5 - New Formulation or New Manufacturer 2026-02-03
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE (EMTRICITABINE)
2026-01-30
YUVEZZI (BRIMONIDINE TARTRATE)
Type 3 - New Dosage Form and Type 4 - New Combination 2026-01-28
QUIOFIC (FOLIC ACID)
Type 3 - New Dosage Form 2026-01-26
AVTOZMA (TOCILIZUMAB-ANOH)
2026-01-21
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
2026-01-21
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE)
2026-01-21
SACUBITRIL AND VALSARTAN (SACUBITRIL)
2026-01-20
ZYCUBO (COPPER HISTIDINATE)
Type 1 - New Molecular Entity PRIORITY 2026-01-12
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE)
2026-01-12
ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
2026-01-07
CIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN)
2026-01-06
NEREUS (TRADIPITANT)
Type 1 - New Molecular Entity 2025-12-30
YARTEMLEA (NARSOPLIMAB-WUUG)
Type 1 - New Molecular Entity PRIORITY 2025-12-23
WEGOVY (SEMAGLUTIDE)
Type 3 - New Dosage Form 2025-12-22
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM (DEXTROMETHORPHAN HYDROBROMIDE)
Type 4 - New Combination 2025-12-22
BONCRESA (DENOSUMAB-MOBZ)
2025-12-19
MYQORZO (AFICAMTEN)
Type 1 - New Molecular Entity 2025-12-19
JASCAYD (NERANDOMILAST)
Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval PRIORITY 2025-12-19
NUFYMCO (RANIBIZUMAB-LEYK)
Type 2 - New Active Ingredient 2025-12-18
RYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ)
Type 5 - New Formulation or New Manufacturer PRIORITY 2025-12-17
EXDENSUR (DEPEMOKIMAB-ULAA)
Type 1 - New Molecular Entity 2025-12-16
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
2025-12-15
CARDAMYST (ETRIPAMIL)
Type 1 - New Molecular Entity 2025-12-12
LEROCHOL (LERODALCIBEP-LIGA)
Type 1 - New Molecular Entity 2025-12-12
NUZOLVENCE (ZOLIFLODACIN)
Type 1 - New Molecular Entity PRIORITY 2025-12-12
DAYBUE STIX (TROFINETIDE)
Type 3 - New Dosage Form 2025-12-11
ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE)
Type 3 - New Dosage Form PRIORITY 2025-12-11
LOTEPREDNOL ETABONATE AND TOBRAMYCIN (LOTEPREDNOL ETABONATE)
2025-12-10
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
2025-12-02
VOYXACT (SIBEPRENLIMAB-SZSI)
Type 1 - New Molecular Entity PRIORITY 2025-11-25
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE)
2025-11-24
No approvals match the selected filters.