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MRK FDA decision dates

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

MRK has 3 upcoming FDA decision dates; the nearest is Mar 22, 2027 for ENFLONSIA (clesrovimab) - second RSV season (SMART). 1 application was withdrawn by the sponsor before a decision; it is listed below. 17 past decisions are on record below, each on its own page.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

Upcoming

Mar 22, 2027 in 137 daysENFLONSIA (clesrovimab) - second RSV season (SMART)Apr 22, 2027 in 168 daysIDVYNSO - treatment-naive HIV-1 (P053) and 96-week data (sNDAs)Jun 15, 2027 in 222 daysSacituzumab tirumotecan (sac-TMT) - endometrial cancer (TroFuse-005)

Withdrawn before a decision

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

Decided

Sep 24, 2026 ✓ ApprovedWelireg (belzutifan) plus Lenvima (lenvatinib)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