Assyro AI

FDA PDUFA dates in August 2026

Published PDUFA target action dates for NDAs, BLAs, ANDAs, and INDs scheduled in August 2026, sourced from FDA primary records.

Tracking 12 published FDA PDUFA decisions, including 4 NDAs and 8 BLAs.

FDA PDUFA dates in August 2026: 12 published FDA PDUFA target action dates. Select a row to expand its full record.
SponsorProductTypeApplicationPDUFA dateStatusExpand and copy
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

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.

August 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

Track August 2026 FDA PDUFA dates for NDA, BLA, ANDA, and IND decisions. Free drug approval tracker with source-linked deadlines, calendar views, and daily updates.