TheraRadar

FDA Fast Track Drug Approvals

179 novel drug approvals with the Fast Track designation, 2016–2025.

Enables more frequent FDA meetings, rolling review of the marketing application, and Priority Review eligibility for drugs filling unmet medical needs in serious conditions.

Key insights (2016–2025)

  • • Fast Track applies to 39% of all FDA novel drug approvals in this period (179 of 458 drugs).
  • • Activity rose 40% (16 → 22/year) in 2023–2025 vs 2020–2022. Peak year: 2023 with 25 approvals.
  • • 125 unique sponsors received this designation; the top sponsor is Merck (5 approvals). Top 5 sponsors account for 13% of all Fast Track approvals.
  • • 85% of Fast Track drugs also received Priority Review designation — the most common pairing.

Approvals by year

2016 8 2017 17 2018 24 2019 17 2020 17 2021 18 2022 12 2023 25 2024 22 2025 19

Top sponsors

Merck 5 Roche 5 Biogen 5 Eli Lilly 4 Sanofi 4 Bristol-Myers Squibb 4 Vertex Pharmaceuticals 3 ASTELLAS 3

All Fast Track approvals

2025
ANDEMBRY (GARADACIMAB-GXII) CSL Behring
2025
ANZUPGO (DELGOCITINIB) LEO PHARMA AS
2025
EKTERLY (SEBETRALSTAT) KALVISTA
2025
ENFLONSIA (CLESROVIMAB-CFOR) Merck
2025
FORZINITY (ELAMIPRETIDE HYDROCHLORIDE) STEALTH BIOTHERAPS
2025
GOMEKLI (MIRDAMETINIB) SPRINGWORKS
2025
HERNEXEOS (ZONGERTINIB) Boehringer Ingelheim
2025
IMAAVY (NIPOCALIMAB-AAHU) Johnson & Johnson
2025
INLURIYO (IMLUNESTRANT TOSYLATE) Eli Lilly
2025
JASCAYD (NERANDOMILAST) Boehringer Ingelheim
2025
JOURNAVX (SUZETRIGINE) Vertex Pharmaceuticals
2025
KOMZIFTI (ZIFTOMENIB) KURA
2025
LYNOZYFIC (LINVOSELTAMAB-GCPT) RENGENERON PHARMACEUTICALS, INC.
2025
NUZOLVENCE (ZOLIFLODACIN) ENTASIS THERAP
2025
PENPULIMAB-KCQX AKESO BIOPHARMA
2025
QFITLIA (FITUSIRAN SODIUM) Sanofi
2025
REDEMPLO (PLOZASIRAN SODIUM) ARROWHEAD
2025
ROMVIMZA (VIMSELTINIB) DECIPHERA PHARMS
2025
WAYRILZ (RILZABRUTINIB) Sanofi
2024
ANKTIVA (nogapendekin alfa inbakicept-pmln) ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
2024
AQNEURSA (LEVACETYLLEUCINE) INTRABIO
2024
BIZENGRI (ZENOCUTUZUMAB-ZBCO) MERUS N.V.
2024
CRENESSITY (CRINECERFONT) NEUROCRINE
2024
DUVYZAT (GIVINOSTAT HYDROCHLORIDE) ITALFARMACO SPA
2024
EBGLYSS (LEBRIKIZUMAB-LBKZ) Eli Lilly
2024
EXBLIFEP (CEFEPIME HYDROCHLORIDE) ORCHID PHARMA
2024
KISUNLA (DONANEMAB-AZBT) Eli Lilly
2024
LEQSELVI (DEURUXOLITINIB PHOSPHATE) Sun Pharma
2024
LUMISIGHT (PEGULICIANINE ACETATE) LUMICELL
2024
MIPLYFFA (ARIMOCLOMOL CITRATE) ZEVRA DENMARK
2024
NIKTIMVO (axatilimab-csfr) INCYTE CORP
2024
ORLYNVAH (PROBENECID) ITERUM THERAP
2024
REVUFORJ (REVUMENIB CITRATE) SYNDAX
2024
REZDIFFRA (RESMETIROM) MADRIGAL
2024
RYTELO (IMETELSTAT SODIUM) GERON
2024
TRYNGOLZA (AUTOINJECTOR) (OLEZARSEN SODIUM) IONIS PHARMS INC
2024
VORANIGO (VORASIDENIB) SERVIER
2024
VYLOY (ZOLBETUXIMAB-CLZB) ASTELLAS
2024
XOLREMDI (MAVORIXAFOR) X4 PHARMS
2024
ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) ISTX
2024
ZIIHERA (ZANIDATAMAB-HRII) JAZZ PHARMS
2023
AGAMREE (VAMOROLONE) CATALYST PHARMS
2023
BEYFORTUS (NIRSEVIMAB-ALIP) AstraZeneca
2023
COLUMVI (GLOFITAMAB-GXBM) Roche
2023
DAYBUE (TROFINETIDE) ACADIA PHARMS INC
2023
DEFENCATH (HEPARIN SODIUM) CORMEDIX
2023
ELFABRIO (PEGUNIGALSIDASE ALFA-IWXJ) CHIESI FARMACEUTICI SPA
2023
ELREXFIO (ELRANATAMAB) Pfizer
2023
FILSUVEZ (BIRCH TRITERPENES) CHIESI
2023
FRUZAQLA (FRUQUINTINIB) Takeda
2023
IZERVAY (AVACINCAPTAD PEGOL SODIUM) ASTELLAS
2023
JAYPIRCA (PIRTOBRUTINIB) LOXO ONCOL
2023
LAMZEDE (VELMANASE ALFA-TYCV) CHIESI FARMACEUTICI SPA
2023
LEQEMBI (LECANEMAB-IRMB) EISAI INC
2023
OGSIVEO (NIROGACESTAT HYDROBROMIDE) SPRINGWORKS
2023
ORSERDU (ELACESTRANT HYDROCHLORIDE) STEMLINE THERAP
2023
PAXLOVID (COPACKAGED) (NIRMATRELVIR) Pfizer
2023
QALSODY (TOFERSEN) Biogen
2023
REZZAYO (REZAFUNGIN ACETATE) MUNDIPHARMA
2023
SKYCLARYS (OMAVELOXOLONE) Biogen
2023
TRUQAP (CAPIVASERTIB) AstraZeneca
2023
VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) DAIICHI SANKYO INC
2023
VEOPOZ (POZELIMAB-BBFG) Regeneron
2023
XACDURO (COPACKAGED) (DURLOBACTAM SODIUM) ENTASIS THERAP
2023
ZURZUVAE (ZURANOLONE) Biogen
2023
ZYNYZ (RETIFANLIMAB-DLWR) INCYTE CORP
2022
AMVUTTRA (VUTRISIRAN SODIUM) ALNYLAM PHARMS INC
2022
ELAHERE (MIRVETUXIMAB SORAVTANSINE-GYNX) IMMUNOGEN INC
2022
KRAZATI (ADAGRASIB) Bristol-Myers Squibb
2022
LYTGOBI (FUTIBATINIB) TAIHO ONCOLOGY
2022
OPDUALAG (NIVOLUMAB) Bristol-Myers Squibb
2022
PYRUKYND (MITAPIVAT SULFATE) AGIOS PHARMS INC
2022
SUNLENCA (LENACAPAVIR SODIUM) Gilead Sciences
2022
TERLIVAZ (TERLIPRESSIN ACETATE) MALLINCKRODT IRELAND
2022
VIVJOA (OTESECONAZOLE) MYCOVIA PHARMS
2022
VONJO (PACRITINIB CITRATE) SOBI
2022
VOQUEZNA TRIPLE PAK (AMOXICILLIN) PHATHOM
2022
XENPOZYME (OLIPUDASE ALFA-RPCP) Sanofi
2021
ADUHELM (ADUCANUMAB-AVWA) Biogen
2021
AMONDYS 45 (CASIMERSEN) Sarepta Therapeutics
2021
BREXAFEMME (IBREXAFUNGERP CITRATE) GSK
2021
BYLVAY (ODEVIXIBAT) IPSEN
2021
CABENUVA KIT (CABOTEGRAVIR) VIIV HLTHCARE
2021
CYTALUX (PAFOLACIANINE SODIUM) ON TARGET LABS
2021
EMPAVELI (PEGCETACOPLAN) APELLIS PHARMS
2021
EXKIVITY (MOBOCERTINIB SUCCINATE) Takeda
2021
KERENDIA (FINERENONE) Bayer
2021
LUMAKRAS (SOTORASIB) Amgen
2021
LUPKYNIS (VOCLOSPORIN) AURINIA
2021
NEXVIAZYME (AVALGLUCOSIDASE ALFA-NGPT) Sanofi
2021
RYLAZE (ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN) JAZZ PHARMS
2021
SAPHNELO (ANIFROLUMAB-FNIA) AstraZeneca
2021
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) Novartis
2021
TRUSELTIQ (INFIGRATINIB PHOSPHATE) HELSINN HLTHCARE
2021
VERQUVO (VERICIGUAT) Merck
2021
VYVGART (EFGARTIGIMOD ALFA) ARGENX BV
2020
ARTESUNATE AMIVAS
2020
AYVAKIT (AVAPRITINIB) BLUEPRINT MEDICINES
2020
DETECTNET (COPPER CU-64 DOTATATE) CURIUM
2020
DOJOLVI (TRIHEPTANOIN) ULTRAGENYX PHARM INC
2020
ENSPRYNG (SATRALIZUMAB) Roche
2020
EVRYSDI (RISDIPLAM) Roche
2020
MARGENZA (MARGETUXIMAB-CMKB) MACROGENICS INC
2020
MONJUVI (TAFASITAMAB-CXIX) MORPHOSYS US INC
2020
OLINVYK (OLICERIDINE) TREVENA
2020
ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) BIOCRYST
2020
QINLOCK (RIPRETINIB) DECIPHERA PHARMS
2020
RUKOBIA (FOSTEMSAVIR TROMETHAMINE) VIIV HLTHCARE
2020
TEPEZZA (TEPROTUMUMAB-TRBW) HORIZON THERAPEUTICS IRELAND
2020
TRODELVY (SACITUZUMAB GOVITECAN-HZIY) IMMUNOMEDICS INC
2020
TUKYSA (TUCATINIB) SEAGEN
2020
VEKLURY (REMDESIVIR) Gilead Sciences
2020
VILTEPSO (VILTOLARSEN) NIPPON SHINYAKU
2019
CABLIVI (CAPLACIZUMAB-YHDP) ABLYNX NV
2019
CAPLYTA (LUMATEPERONE TOSYLATE) INTRA-CELLULAR
2019
EGATEN (TRICLABENDAZOLE) Novartis
2019
ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) DAIICHI SANKYO INC
2019
FETROJA (CEFIDEROCOL SULFATE TOSYLATE) SHIONOGI
2019
NUBEQA (DAROLUTAMIDE) Bayer
2019
OXBRYTA (VOXELOTOR) GLOBAL BLOOD THERAPS
2019
PRETOMANID Viatris
2019
REBLOZYL (LUSPATERCEPT-AAMT) Bristol-Myers Squibb
2019
RECARBRIO (CILASTATIN SODIUM) Merck
2019
SCENESSE (AFAMELANOTIDE) CLIVUNEL INC
2019
TRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) Vertex Pharmaceuticals
2019
VYNDAQEL (TAFAMIDIS MEGLUMINE) FOLDRX PHARMS
2019
VYONDYS 53 (GOLODIRSEN) Sarepta Therapeutics
2019
WAKIX (PITOLISANT HYDROCHLORIDE) HARMONY
2019
XENLETA (LEFAMULIN ACETATE) HONG KONG
2019
XPOVIO (SELINEXOR) KARYOPHARM THERAPS
2018
AEMCOLO (RIFAMYCIN SODIUM) COSMO TECHNOLOGIES
2018
COPIKTRA (DUVELISIB) SECURA
2018
CRYSVITA (BUROSUMAB-TWZA) KYOWA KIRIN
2018
EPIDIOLEX (CANNABIDIOL) JAZZ PHARMS RES
2018
ERLEADA (APALUTAMIDE) Johnson & Johnson
2018
GALAFOLD (MIGALASTAT HYDROCHLORIDE) AMICUS THERAP US
2018
LUCEMYRA (LOFEXIDINE HYDROCHLORIDE) BIOCORRX PHARMS
2018
LUMOXITI (MOXETUMOMAB PASUDOTOX-TDFK) INNATE PHARMA
2018
LUTATHERA (LUTETIUM LU 177 DOTATATE) AAA USA INC
2018
MULPLETA (LUSUTROMBOPAG) VANCOCIN ITALIA
2018
NUZYRA (OMADACYCLINE TOSYLATE) PARATEK PHARMS
2018
OMEGAVEN (FISH OIL TRIGLYCERIDES) Fresenius Kabi
2018
ONPATTRO (PATISIRAN SODIUM) ALNYLAM PHARMS INC
2018
OXERVATE (CENEGERMIN-BKBJ) DOMPE FARMACEUTICI
2018
PALYNZIQ (PEGVALIASE-PQPZ) BIOMARIN PHARM
2018
REVCOVI (ELAPEGADEMASE-LVLR) CHIESI USA INC
2018
SYMDEKO (COPACKAGED) (IVACAFTOR) Vertex Pharmaceuticals
2018
TAKHZYRO (LANADELUMAB-FLYO) DYAX CORP.
2018
TEGSEDI (INOTERSEN SODIUM) AKCEA THERAPS
2018
TIBSOVO (IVOSIDENIB) SERVIER
2018
TPOXX (TECOVIRIMAT) SIGA TECHNOLOGIES
2018
TROGARZO (IBALIZUMAB-UIYK) THERATECHNOLOGIES
2018
XERAVA (ERAVACYCLINE DIHYDROCHLORIDE) TETRAPHASE PHARMS
2018
XOSPATA (GILTERITINIB FUMARATE) ASTELLAS
2017
ALIQOPA (COPANLISIB DIHYDROCHLORIDE) Bayer
2017
BAVENCIO (AVELUMAB) EMD SERONO INC
2017
BAXDELA (DELAFLOXACIN MEGLUMINE) MELINTA
2017
BEVYXXA (BETRIXABAN) PORTOLA PHARMS INC
2017
EMFLAZA (DEFLAZACORT) PTC THERAP
2017
IDHIFA (ENASIDENIB MESYLATE) Bristol-Myers Squibb
2017
INGREZZA (VALBENAZINE TOSYLATE) NEUROCRINE
2017
MAVYRET (GLECAPREVIR) AbbVie
2017
MEPSEVII (VESTRONIDASE ALFA-VJBK) ULTRAGENYX PHARM INC
2017
OCREVUS (OCRELIZUMAB) Roche
2017
PREVYMIS (LETERMOVIR) Merck
2017
RYDAPT (MIDOSTAURIN) Novartis
2017
SOLOSEC (SECNIDAZOLE) EVOFEM INC
2017
VABOMERE (MEROPENEM) REMPEX
2017
VERZENIO (ABEMACICLIB) Eli Lilly
2017
XERMELO (TELOTRISTAT ETIPRATE) TERSERA
2017
ZEJULA (NIRAPARIB TOSYLATE) GSK
2016
DEFITELIO (DEFIBROTIDE SODIUM) JAZZ PHARMS
2016
EPCLUSA (SOFOSBUVIR) Gilead Sciences
2016
EXONDYS 51 (ETEPLIRSEN) Sarepta Therapeutics
2016
RUBRACA (RUCAPARIB CAMSYLATE) PHARMAAND
2016
SPINRAZA (NUSINERSEN SODIUM) Biogen
2016
TECENTRIQ (ATEZOLIZUMAB) Roche
2016
VENCLEXTA (VENETOCLAX) AbbVie
2016
ZEPATIER (ELBASVIR) Merck

Other FDA designations

First-in-Class Orphan Drug Breakthrough Therapy Accelerated Approval Priority Review

Designation data from FDA Center for Drug Evaluation and Research (CDER) annual New Drug Therapy Approvals reports, 2016–2025. Each drug is counted once per the year of its novel approval; many drugs hold multiple designations.

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