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FDA PDUFA dates in July 2026

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

Tracking 12 published FDA PDUFA decisions, including 7 NDAs and 5 BLAs.

FDA PDUFA dates in July 2026: 12 published FDA PDUFA target action dates. Select a row to expand its full record.
SponsorProductTypeApplicationPDUFA dateStatusExpand and copy
Ascelia PharmaOrviglanceNDAPENDING-provisional|asceliapharma|orviglance|liverimaginoverdue
Orca BioOrca-TBLAPENDING-provisional|orcabio|orcat|hematologicmalignancieoverdue
Vera TherapeuticsataciceptBLAPENDING-provisional|veratherapeutics|atacicept|iganephrooverdue
Daiichi Sankyo and AstraZenecaENHERTUBLAPENDING-provisional|daiichisankyoandastrazeneca|enhertu|overdue
Corcept Therapeuticsrelacorilant + nab-paclitaxelNDAPENDING-provisional|corcepttherapeutics|relacorilantnabpoverdue
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

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.

July 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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