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Upcoming FDA PDUFA dates (next 90 days)

Published PDUFA target action dates for NDAs, BLAs, ANDAs, and INDs scheduled in the next 90 days, sourced from FDA primary records and updated daily.

Tracking 26 published FDA PDUFA decisions, including 16 NDAs and 10 BLAs.

Upcoming FDA PDUFA dates (next 90 days): 26 published FDA PDUFA target action dates.
SponsorProductTypeApplicationPDUFA dateStatus
Eisai and BiogenLEQEMBI IQLIKBLAPENDING-provisional|eisaiandbiogen|leqembiiqlik|subcutanupcoming
MannKindAfrezzaBLAPENDING-provisional|mannkind|afrezza|diabetesinchildrenaupcoming
CingulateCTx-1301NDAPENDING-provisional|cingulate|ctx1301|attentiondeficithyupcoming
Daiichi Sankyo and AstraZenecaDATROWAYBLAPENDING-provisional|daiichisankyoandastrazeneca|datrowayupcoming
ArvinasvepdegestrantNDAPENDING-provisional|arvinas|vepdegestrant|esr1mutatederpupcoming
GSK and Spero Therapeuticstebipenem HBrNDAPENDING-provisional|gskandsperotherapeutics|tebipenemhbrupcoming
MerckKEYTRUDA + WELIREGBLAPENDING-provisional|merck|keytrudawelireg|adjuvanttreatmupcoming
Arcutis BiotherapeuticsZORYVE cream 0.3%NDAPENDING-provisional|arcutisbiotherapeutics|zoryvecream03upcoming
LantheusLNTH-2501 (Ga 68 edotreotide)NDAPENDING-provisional|lantheus|lnth2501ga68edotreotide|petupcoming
Unicycive Therapeuticsoxylanthanum carbonateNDAPENDING-provisional|unicycivetherapeutics|oxylanthanumcaupcoming
Ionis PharmaceuticalsolezarsenNDAPENDING-provisional|ionispharmaceuticals|olezarsen|severupcoming
Viridian TherapeuticsveligrotugBLAPENDING-provisional|viridiantherapeutics|veligrotug|thyrupcoming
Ascelia PharmaOrviglanceNDAPENDING-provisional|asceliapharma|orviglance|liverimaginupcoming
Vera TherapeuticsataciceptBLAPENDING-provisional|veratherapeutics|atacicept|iganephroupcoming
Daiichi Sankyo and AstraZenecaENHERTUBLAPENDING-provisional|daiichisankyoandastrazeneca|enhertu|upcoming
Corcept Therapeuticsrelacorilant + nab-paclitaxelNDAPENDING-provisional|corcepttherapeutics|relacorilantnabpupcoming
CelcuitygedatolisibNDAPENDING-provisional|celcuity|gedatolisib|hrpositiveher2nupcoming
Elevar Therapeuticsrivoceranib + camrelizumabNDAPENDING-provisional|elevartherapeutics|rivoceranibcamrelupcoming
SanofiSarclisa SCBLAPENDING-provisional|sanofi|sarclisasc|multiplemyeloma|20upcoming
Otsuka PharmaceuticalcentanafadineNDAPENDING-provisional|otsukapharmaceutical|centanafadine|aupcoming
MannKindFUROSCIX ReadyFlow AutoinjectorNDAPENDING-provisional|mannkind|furoscixreadyflowautoinjectupcoming
Viatrislow-dose estrogen weekly patchNDAPENDING-provisional|viatris|lowdoseestrogenweeklypatch|cupcoming
ModernamRNA-1010BLAPENDING-provisional|moderna|mrna1010|seasonalinfluenzaprupcoming
LantheusMK-6240NDAPENDING-provisional|lantheus|mk6240|petimagingagenttargeupcoming
Bristol Myers Squibbiberdomide + daratumumab/dexamethasoneNDAPENDING-provisional|bristolmyerssquibb|iberdomidedaratumupcoming
Merck, Astellas, and PfizerKEYTRUDA + PADCEVBLAPENDING-provisional|merckastellasandpfizer|keytrudapadceupcoming

Use the calendar, timeline, status board, or table views above to filter, sort, and inspect source-linked details.

FDA PDUFA Calendar: Drug Approval Dates & Deadlines

Track FDA PDUFA dates for NDA, BLA, ANDA, and IND decisions. Free drug approval tracker with source-linked deadlines, calendar views, and daily updates.