pdufa.bio

MRK FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

MRK has no FDA decision date ahead on the pdufa.bio calendar. 1 application was withdrawn by the sponsor before a decision; it is listed below. 16 past decisions are on record below, each on its own page.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.

MRK catalyst hub · full calendar

Withdrawn before a decision

Sep 25, 2026 WithdrawnIfinatamab deruxtecan (I-DXd), before its Oct 10, 2026 goal date

Decided

Sep 22, 2026 ✓ ApprovedWINREVAIR (sotatercept-csrk)Jul 16, 2026 ✓ ApprovedLipfendra (enlicitide decanoate, MK-0616)Jul 10, 2026 ✓ ApprovedKEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYNJun 24, 2026 ✓ ApprovedTrodelvy (sacituzumab govitecan-hziy)Jun 18, 2026 ✓ ApprovedCAPVAXIVEJun 12, 2026 ✓ ApprovedKEYTRUDA (pembrolizumab)Apr 21, 2026 ✓ ApprovedIDVYNSO (doravirine/islatravir)Feb 20, 2026 ✓ ApprovedKEYTRUDA + chemo ± bevacizumabFeb 11, 2026 ✓ ApprovedKEYTRUDA and KEYTRUDA QLEXDec 17, 2025 CRLprice-onlyNov 21, 2025 ✓ ApprovedPADCEVOct 27, 2025 ✓ ApprovedWINREVAIRSep 19, 2025 ✓ ApprovedKEYTRUDA QLEXJun 13, 2025 ✓ ApprovedKEYTRUDAJun 9, 2025 ✓ Approvedprice-onlyMay 14, 2025 ✓ ApprovedWELIREG