pdufa.bio

AZN FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

AZN has no FDA decision date ahead on the pdufa.bio calendar. 18 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.

AZN catalyst hub · full calendar

Decided

Oct 21, 2026 ✓ ApprovedUltomiris (ravulizumab)Sep 4, 2026 ✓ ApprovedEtcamah (camizestrant)Jun 12, 2026 ✓ ApprovedTRUQAP (capivasertib)May 28, 2026 ✓ ApprovedImfinzi (durvalumab)May 22, 2026 ✓ ApprovedDatopotamab Deruxtecan (Dato-DXd)May 18, 2026 ✓ ApprovedBAXFENDY (baxdrostat)May 15, 2026 ✓ ApprovedENHERTU (trastuzumab deruxtecan)Apr 28, 2026 ✓ ApprovedBREZTRI AEROSPHEREApr 27, 2026 ✓ ApprovedSAPHNELO (anifrolumab-fnia)Feb 20, 2026 ✓ Approvedprice-onlyDec 15, 2025 ✓ ApprovedEnhertuNov 25, 2025 ✓ ApprovedImfinziNov 20, 2025 ✓ ApprovedKoselugoOct 17, 2025 ✓ ApprovedTEZSPIREJun 23, 2025 ✓ ApprovedDATROWAYMar 31, 2025 ✓ ApprovedIMFINZIJan 27, 2025 ✓ ApprovedEnhertuJan 17, 2025 ✓ ApprovedDatopotamab Deruxtecan