Recent FDA Approvals
BETA324
New Drugs 2026
-512 vs 2025
129
NDA (Small Molecule)
71
BLA (Biologics)
50
From Biotechs
New Drug Approvals by Year
876 2022
921 2023
865 2024
836 2025
324 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:
Designation:
IMMGOLIS (GOLIMUMAB-SLDI)
Type 5 - New Formulation or New Manufacturer 2026-05-15
TRIMBOW (BECLOMETHASONE DIPROPIONATE, FORMOTEROL FUMARATE, AND GLYCOPYRROLATE)
Type 4 - New Combination 2026-05-14
BEQALZI (SONROTOCLAX)
Type 1 - New Molecular Entity PRIORITY 2026-05-13
EVDI (TRABECTEDIN)
Type 5 - New Formulation or New Manufacturer 2026-05-01
VEPPANU (VEPDEGESTRANT)
Type 1 - New Molecular Entity 2026-05-01
JAKAFI XR (RUXOLITINIB PHOSPHATE)
Type 5 - New Formulation or New Manufacturer 2026-05-01
LANGLARA (INSULIN GLARGINE-ALDY)
2026-04-29
SAPHNELO (ANIFROLIMAB-FNIA)
Type 5 - New Formulation or New Manufacturer 2026-04-24
IDVYNSO (DORAVIRINE)
Type 1 - New Molecular Entity and Type 4 - New Combination 2026-04-20
FOUNDAYO (ORFORGLIPRON CALCIUM)
Type 1 - New Molecular Entity 2026-04-01
New Combination and New Formulation or New Manufacturer 2026-03-30
PONLIMSI (DENOSUMAB-ADET)
Type 5 - New Formulation or New Manufacturer 2026-03-27
AWIQLI FLEXTOUCH (INSULIN ICODEC)
Type 1 - New Molecular Entity 2026-03-26
LIFYORLI (COPACKAGED) (RELACORILANT)
Type 1 - New Molecular Entity 2026-03-25
AVLAYAH (TIVIDENOFUSP ALFA-EKNM)
Type 1 - New Molecular Entity PRIORITY 2026-03-24
ATONCY (ATOMOXETINE HYDROCHLORIDE)
Type 3 - New Dosage Form 2026-03-20
FLAVALTA (EPINEPHRINE BITARTRATE)
Type 5 - New Formulation or New Manufacturer 2026-03-19
ICOTYDE (ICOTROKINRA HYDROCHLORIDE)
Type 1 - New Molecular Entity PRIORITY 2026-03-17
LYNAVOY (LINERIXIBAT)
Type 1 - New Molecular Entity 2026-03-17
PYLARIFY TRUVU (PIFLUFOLASTAT F-18)
Type 5 - New Formulation or New Manufacturer 2026-03-06
PREZCOBIX (DARUNAVIR AND COBICISTAT)
Type 3 - New Dosage Form 2026-02-27
Type 5 - New Formulation or New Manufacturer 2026-02-27
YUVIWEL (NAVEPEGRITIDE)
Type 1 - New Molecular Entity PRIORITY 2026-02-27
DESMODA (DESMOPRESSIN ACETATE)
Type 3 - New Dosage Form 2026-02-25
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
UNKNOWN 2026-02-17
RYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ)
Type 5 - New Formulation or New Manufacturer 2026-02-13
AVOPEF (ETOPOSIDE)
Type 3 - New Dosage Form 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
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
ZYCUBO (COPPER HISTIDINATE)
Type 1 - New Molecular Entity PRIORITY 2026-01-12
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
JASCAYD (NERANDOMILAST)
Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval PRIORITY 2025-12-19
MYQORZO (AFICAMTEN)
Type 1 - New Molecular Entity 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
VYBRIQUE (SILDENAFIL CITRATE)
Type 3 - New Dosage Form 2025-12-16
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
ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE)
Type 3 - New Dosage Form PRIORITY 2025-12-11
DAYBUE STIX (TROFINETIDE)
Type 3 - New Dosage Form 2025-12-11
waskyra (etuvetidigene autotemcel)
CBER biologic (Purple Book) 2025-12-08
avance nerve graft (acellular nerve allograft-arwx)
CBER biologic (Purple Book) 2025-12-02
EPYSQLI (ECULIZUMAB-AAGH)
Efficacy 2025-11-28
VOYXACT (SIBEPRENLIMAB-SZSI)
Type 1 - New Molecular Entity PRIORITY 2025-11-25
ITVISMA (onasemnogene abeparvovec-brve)
CBER biologic (Purple Book) 2025-11-23
HYRNUO (SEVABERTINIB)
Type 1 - New Molecular Entity PRIORITY 2025-11-19
REDEMPLO (PLOZASIRAN SODIUM)
Type 1 - New Molecular Entity 2025-11-18
KOMZIFTI (ZIFTOMENIB)
Type 1 - New Molecular Entity PRIORITY 2025-11-13
KYGEVVI (DOXECITINE)
Type 1 - New Molecular Entity PRIORITY 2025-11-03
OSENVELT (DENOSUMAB-BMWO)
Efficacy 2025-10-29
Efficacy 2025-10-29
OSVYRTI (denosumab-desu)
2025-10-29
BILPREVDA (DENOSUMAB-NXXP)
Efficacy 2025-10-29
ENOBY (DENOSUMAB-QBDE)
Efficacy 2025-10-29
AUKELSO (DENOSUMAB-KYQQ)
Efficacy 2025-10-29
CONEXXENCE (DENOSUMAB-BNHT)
Efficacy 2025-10-29
CARBON DIOXIDE, USP (CARBON DIOXIDE)
UNKNOWN 2025-10-25
LYNKUET (ELINZANETANT)
Type 1 - New Molecular Entity 2025-10-24
JAVADIN (CLONIDINE HYDROCHLORIDE)
Type 3 - New Dosage Form 2025-10-23
BLENREP (BELANTAMAB MAFODOTIN-BLMF)
Type 2 - New Active Ingredient 2025-10-23
Type 5 - New Formulation or New Manufacturer 2025-10-23
CONTEPO (FOSFOMYCIN DISODIUM)
Type 2 - New Active Ingredient PRIORITY 2025-10-22
EPIOXA HD/EPIOXA KIT (RIBOFLAVIN 5'-PHOSPHATE SODIUM)
Type 5 - New Formulation or New Manufacturer 2025-10-17
FERABRIGHT (FERUMOXYTOL)
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated 2025-10-16
Unknown Drug
Type 9 - New indication submitted as distinct BLA, consolidated PRIORITY 2025-10-15
JASCAYD (NERANDOMILAST)
Type 1 - New Molecular Entity PRIORITY 2025-10-07
LASIX ONYU (FUROSEMIDE)
Type 3 - New Dosage Form 2025-10-07
EYDENZELT (AFLIBERCEPT-BOAV)
Type 3 - New Dosage Form 2025-10-02
RHAPSIDO (REMIBRUTINIB)
Type 1 - New Molecular Entity PRIORITY 2025-09-30
CLOTIC (CLOTRIMAZOLE)
Type 3 - New Dosage Form PRIORITY 2025-09-26
QIVIGY (Immune Globulin Intravenous, Human-kthm, 10% Solution)
CBER biologic (Purple Book) 2025-09-25
PALSONIFY (PALTUSOTINE HYDROCHLORIDE)
Type 1 - New Molecular Entity 2025-09-25
INLURIYO (IMLUNESTRANT TOSYLATE)
Type 1 - New Molecular Entity 2025-09-25
BONDLIDO (LIDOCAINE)
Type 5 - New Formulation or New Manufacturer 2025-09-24
FORZINITY (ELAMIPRETIDE HYDROCHLORIDE)
Type 1 - New Molecular Entity PRIORITY 2025-09-19
KEYTRUDA QLEX (PEMBROLIZUMAB)
Efficacy PRIORITY 2025-09-19
KEYTRUDA QLEX (PEMBROLIZUMAB)
Type 1 - New Molecular Entity PRIORITY 2025-09-19
AUKELSO (DENOSUMAB-KYQQ)
2025-09-16
SUBVENITE (LAMOTRIGINE)
Type 3 - New Dosage Form 2025-09-16
ENBUMYST (BUMETANIDE)
Type 3 - New Dosage Form 2025-09-12
KOSELUGO (SELUMETINIB)
Type 3 - New Dosage Form PRIORITY 2025-09-10
ZOLYMBUS (BIMATOPROST)
Type 3 - New Dosage Form 2025-09-09
INLEXZO (GEMCITABINE HYDROCHLORIDE)
Type 3 - New Dosage Form PRIORITY 2025-09-09
OTEZLA (APREMILAST)
Type 5 - New Formulation or New Manufacturer 2025-08-29
OTEZLA (APREMILAST)
Type 5 - New Formulation or New Manufacturer 2025-08-29
LEQEMBI IQLIK (LECANEMAB-IRMB)
2025-08-29
ESCITALOPRAM (ESCITALOPRAM OXALATE)
Type 3 - New Dosage Form 2025-08-29
BILPREVDA (DENOSUMAB-NXXP)
2025-08-29
WAYRILZ (RILZABRUTINIB)
Type 1 - New Molecular Entity 2025-08-29
LOPRESSOR (METOPROLOL TARTRATE)
Type 5 - New Formulation or New Manufacturer 2025-08-28
CAMCEVI ETM (LEUPROLIDE MESYLATE)
Type 5 - New Formulation or New Manufacturer 2025-08-25
DAWNZERA (AUTOINJECTOR) (DONIDALORSEN SODIUM)
Type 1 - New Molecular Entity 2025-08-21
CYKLX (ARTICAINE HYDROCHLORIDE)
Type 3 - New Dosage Form and Type 4 - New Combination 2025-08-15
TONMYA (CYCLOBENZAPRINE HYDROCHLORIDE)
Type 3 - New Dosage Form 2025-08-15
PAPZIMEOS (zopapogene imadenovec-drba)
CBER biologic (Purple Book) 2025-08-13
BRINSUPRI (BRENSOCATIB)
Type 1 - New Molecular Entity PRIORITY 2025-08-12
KYXATA (CARBOPLATIN)
Type 5 - New Formulation or New Manufacturer 2025-08-08
HERNEXEOS (ZONGERTINIB)
Type 1 - New Molecular Entity PRIORITY 2025-08-08
MODEYSO (DORDAVIPRONE HYDROCHLORIDE)
Type 1 - New Molecular Entity PRIORITY 2025-08-06
E-Z-DISK (BARIUM SULFATE)
Type 7 - Drug Already Marketed without Approved NDA 2025-08-01
VIZZ (ACECLIDINE HYDROCHLORIDE)
Type 1 - New Molecular Entity 2025-07-31
ALHEMO (CONCIZUMAB)
Type 9 - New indication submitted as distinct BLA, consolidated 2025-07-31
VYSCOXA (CELECOXIB)
Type 3 - New Dosage Form 2025-07-29
SEPHIENCE (SEPIAPTERIN)
Type 1 - New Molecular Entity 2025-07-28
SDAMLO (AMLODIPINE BESYLATE)
Type 3 - New Dosage Form 2025-07-24
DOPTELET SPRINKLE (AVATROMBOPAG MALEATE)
Type 3 - New Dosage Form 2025-07-24
ANZUPGO (DELGOCITINIB)
Type 1 - New Molecular Entity 2025-07-23
VOSTALLY (RAMIPRIL)
Type 3 - New Dosage Form 2025-07-23
Type 5 - New Formulation or New Manufacturer 2025-07-16
KIRSTY (INSULIN ASPART-XJHZ)
Type 5 - New Formulation or New Manufacturer 2025-07-15
EKTERLY (SEBETRALSTAT)
Type 1 - New Molecular Entity 2025-07-03
Type 5 - New Formulation or New Manufacturer 2025-07-03
ZEGFROVY (SUNVOZERTINIB)
Type 1 - New Molecular Entity PRIORITY 2025-07-02
LYNOZYFIC (LINVOSELTAMAB-GCPT)
Type 1 - New Molecular Entity PRIORITY 2025-07-02
AVGEMSI (GEMCITABINE HYDROCHLORIDE)
Type 5 - New Formulation or New Manufacturer 2025-06-27
DATROWAY (DATOPOTAMAB DERUXTECAN-DLNK)
Type 1 - New Molecular Entity PRIORITY 2025-06-23
YEZTUGO (LENACAPAVIR SODIUM)
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated PRIORITY 2025-06-18
YEZTUGO (LENACAPAVIR)
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated PRIORITY 2025-06-18
CARBON DIOXIDE, USP (CARBON DIOXIDE)
UNKNOWN 2025-06-16
ANDEMBRY (GARADACIMAB-GXII)
Type 1 - New Molecular Entity 2025-06-16
ARYNTA (LISDEXAMFETAMINE DIMESYLATE)
Type 3 - New Dosage Form 2025-06-16
ZUSDURI (MITOMYCIN)
Type 3 - New Dosage Form 2025-06-12
IBTROZI (TALETRECTINIB ADIPATE)
Type 1 - New Molecular Entity PRIORITY 2025-06-11
BRUKINSA (ZANUBRUTINIB)
Type 3 - New Dosage Form 2025-06-10
BRUKINSA (ZANUBRUTINIB)
Type 3 - New Dosage Form 2025-06-10
Type 5 - New Formulation or New Manufacturer 2025-06-09
ENFLONSIA (CLESROVIMAB-CFOR)
Type 1 - New Molecular Entity PRIORITY 2025-06-09
WIDAPLIK (AMLODIPINE BESYLATE)
Type 4 - New Combination 2025-06-05
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
Type 5 - New Formulation or New Manufacturer 2025-05-30
TRYPTYR (ACOLTREMON)
Type 1 - New Molecular Entity 2025-05-28
KHINDIVI (HYDROCORTISONE)
Type 3 - New Dosage Form 2025-05-28
YUTREPIA (TREPROSTINIL SODIUM)
Type 5 - New Formulation or New Manufacturer 2025-05-23
STARJEMZA (USTEKINUMAB-HMNY)
Type 2 - New Active Ingredient 2025-05-22
NUVAXOVID (COVID-19 Vaccine, Adjuvanted)
CBER biologic (Purple Book) 2025-05-15
EMRELIS (TELISOTUZUMAB VEDOTIN-TLLV)
Type 1 - New Molecular Entity PRIORITY 2025-05-14
BREKIYA (AUTOINJECTOR) (DIHYDROERGOTAMINE MESYLATE)
Type 5 - New Formulation or New Manufacturer 2025-05-14
AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (AVUTOMETINIB POTASSIUM)
Type 1 - New Molecular Entity PRIORITY 2025-05-08
PYZCHIVA (USTEKINUMAB-TTWE)
Type 3 - New Dosage Form 2025-04-30
PYZCHIVA (USTEKINUMAB-TTWE)
Type 2 - New Active Ingredient 2025-04-30
STEQEYMA (USTEKINUMAB-STBA)
Type 2 - New Active Ingredient 2025-04-30
ATZUMI (DIHYDROERGOTAMINE MESYLATE)
Type 3 - New Dosage Form 2025-04-30
YESINTEK (USTEKINUMAB-KFCE)
2025-04-30
IMAAVY (NIPOCALIMAB-AAHU)
Type 1 - New Molecular Entity PRIORITY 2025-04-29
zevaskyn (Prademagene zamikeracel)
CBER biologic (Purple Book) 2025-04-27
Type 1 - New Molecular Entity 2025-04-23
QAMZOVA (MELOXICAM)
Type 5 - New Formulation or New Manufacturer 2025-04-22
CARBON DIOXIDE, USP (CARBON DIOXIDE)
UNKNOWN 2025-04-21
ELIQUIS (APIXABAN)
Type 3 - New Dosage Form PRIORITY 2025-04-17
MEZOFY (ARIPIPRAZOLE)
Type 3 - New Dosage Form 2025-04-15
LOPRESSOR (METOPROLOL TARTRATE)
Type 3 - New Dosage Form 2025-04-10
LIVMARLI (MARALIXIBAT CHLORIDE)
Type 3 - New Dosage Form 2025-04-10
JOBEVNE (BEVACIZUMAB-NWGD)
Type 5 - New Formulation or New Manufacturer 2025-04-09
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER (PIPERACILLIN SODIUM)
Type 5 - New Formulation or New Manufacturer 2025-04-03
VANRAFIA (ATRASENTAN HYDROCHLORIDE)
Type 1 - New Molecular Entity 2025-04-02
QFITLIA (FITUSIRAN SODIUM)
Type 1 - New Molecular Entity 2025-03-28
VYKAT XR (DIAZOXIDE CHOLINE)
Type 2 - New Active Ingredient PRIORITY 2025-03-26
BLUJEPA (GEPOTIDACIN MESYLATE)
Type 1 - New Molecular Entity PRIORITY 2025-03-25
Egrifta WR (tesamorelin)
CBER biologic (Purple Book) 2025-03-24
GOZELLIX (GALLIUM GA-68 GOZETOTIDE)
Type 5 - New Formulation or New Manufacturer 2025-03-20
HEMICLOR (CHLORTHALIDONE)
Type 3 - New Dosage Form 2025-03-17
TYENNE (TOCILIZUMAB-AAZG)
2025-03-14
ARBLI (LOSARTAN POTASSIUM)
Type 3 - New Dosage Form 2025-03-13
Type 5 - New Formulation or New Manufacturer 2025-03-13
encelto (revakinagene taroretcel-lwey)
CBER biologic (Purple Book) 2025-03-04
TEVIMBRA (islelizumab-jsgr)
Type 9 - New indication submitted as distinct BLA, consolidated 2025-03-03
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (EPINEPHRINE BITARTRATE)
Type 5 - New Formulation or New Manufacturer 2025-02-28
MIUDELLA (COPPER)
Type 5 - New Formulation or New Manufacturer 2025-02-24
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE (DILTIAZEM HYDROCHLORIDE)
Type 5 - New Formulation or New Manufacturer 2025-02-21
CTEXLI (CHENODIOL)
Type 5 - New Formulation or New Manufacturer PRIORITY 2025-02-21
Type 3 - New Dosage Form 2025-02-19
ROMVIMZA (VIMSELTINIB)
Type 1 - New Molecular Entity PRIORITY 2025-02-14
MERILOG (INSULIN ASPART-SZJJ)
2025-02-14
No approvals match the selected filters.