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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 32 published FDA PDUFA decisions, including 18 NDAs and 14 BLAs.

Upcoming FDA PDUFA dates (next 90 days): 32 published FDA PDUFA target action dates. Select a row to expand its full record.
SponsorProductTypeApplicationPDUFA dateStatusExpand and copy
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
Outlook Therapeutics, Inc.ONS-5010 (bevacizumab-vikg) / LYTENAVABLAPENDING-provisional|outlooktherapeuticsinc|ons5010bevaciupcoming
Viatrislow-dose estrogen weekly patchNDAPENDING-provisional|viatris|lowdoseestrogenweeklypatch|cupcoming
Replimune GroupRP1 (vusolimogene oderparepvec)BLAPENDING-provisional|replimunegroup|rp1vusolimogeneoderpaupcoming
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
Capricor TherapeuticsderamiocelBLAPENDING-provisional|capricortherapeutics|deramiocel|duchupcoming
Ultragenyx PharmaceuticalDTX401BLAPENDING-provisional|ultragenyxpharmaceutical|dtx401|glycupcoming
Eisai and BiogenLEQEMBI IQLIKBLAPENDING-provisional|eisaiandbiogen|leqembiiqlik|subcutanupcoming
Jazz PharmaceuticalsZiiheraBLAPENDING-provisional|jazzpharmaceuticals|ziihera|firstlinupcoming
Gilead Sciencesbictegravir/lenacapavirNDAPENDING-provisional|gileadsciences|bictegravirlenacapaviupcoming
ITM Isotope Technologies Munich177Lu-edotreotideNDAPENDING-provisional|itmisotopetechnologiesmunich|177luedupcoming
PharmaEssentiaBESREMiBLAPENDING-provisional|pharmaessentia|besremi|essentialthroupcoming
AdvicenneSibnayalNDAPENDING-provisional|advicenne|sibnayal|distalrenaltubulaupcoming
Telix PharmaceuticalsTLX101-Px (Pixclara)NDAPENDING-provisional|telixpharmaceuticals|tlx101pxpixclarupcoming
NuvalentzidesamtinibNDAPENDING-provisional|nuvalent|zidesamtinib|ros1positivenoupcoming
Ultragenyx PharmaceuticalUX111BLAPENDING-provisional|ultragenyxpharmaceutical|ux111|sanfiupcoming
MerckWINREVAIRBLAPENDING-provisional|merck|winrevair|pulmonaryarterialhypupcoming
Ionis PharmaceuticalszilganersenNDAPENDING-provisional|ionispharmaceuticals|zilganersen|aleupcoming
Incyte Corporation / Mirum PharmaceuticalsZilurgisertibNDAPENDING-provisional|incytecorporationmirumpharmaceuticalupcoming
Praxis Precision MedicinesrelutrigineNDAPENDING-provisional|praxisprecisionmedicines|relutrigineupcoming
BiofronteraAmeluz-PDTNDAPENDING-provisional|biofrontera|ameluzpdt|superficialbasupcoming
Egetis TherapeuticsEmcitate (tiratricol)NDAPENDING-provisional|egetistherapeutics|emcitatetiratricoupcoming
Scholar RockapitegromabBLAPENDING-provisional|scholarrock|apitegromab|spinalmusculupcoming
Merck and EisaiWELIREG + LENVIMANDAPENDING-provisional|merckandeisai|welireglenvima|advanceupcoming
Daiichi Sankyo and Merckifinatamab deruxtecanBLAPENDING-provisional|daiichisankyoandmerck|ifinatamabderuupcoming

Select any row to expand its full record. 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.