pdufa.bio

PFE FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

PFE has no FDA decision date ahead on the pdufa.bio calendar. 11 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

PFE catalyst hub · full calendar

Decided

Oct 7, 2026 ✓ ApprovedTukysa (tucatinib) + trastuzumab + pertuzumab - HER2+ metastatic breasAug 27, 2026 ✓ ApprovedLISRAYA (brepocitinib)Jul 10, 2026 ✓ ApprovedKEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYNJun 24, 2026 ✓ ApprovedIBRANCE (palbociclib)Jun 8, 2026 ✓ ApprovedHYMPAVZI (marstacimab)May 1, 2026 ✓ ApprovedVEPPANU (vepdegestrant)Feb 24, 2026 ✓ ApprovedBRAFTOVI (encorafenib)Dec 17, 2025 CRLprice-onlyNov 21, 2025 ✓ ApprovedPADCEVAug 27, 2025 ✓ Approvedprice-onlyFeb 12, 2025 ✓ ApprovedADCETRIS