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MRK FDA decision dates

Updated ·next FDA decision on the calendar

MRK has 2 upcoming FDA decision dates; the nearest is Sep 21, 2026 for WINREVAIR (sotatercept-csrk) - (HYPERION). 15 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

Sep 21, 2026 in 6 daysWINREVAIR (sotatercept-csrk) - (HYPERION)Oct 10, 2026 in 25 daysIfinatamab deruxtecan (I-DXd)

Decided

Jul 16, 2026 ✓ ApprovedLipfendra (enlicitide): first oral PCSK9 inhibitorJul 10, 2026 ✓ ApprovedKEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYNJun 24, 2026 ✓ ApprovedTrodelvy (sacituzumab govitecaJun 18, 2026 ✓ ApprovedCAPVAXIVE (Pneumococcal 21-valJun 12, 2026 ✓ ApprovedKEYTRUDA (pembrolizumab) and KApr 21, 2026 ✓ ApprovedIDVYNSO (doravirine/islatravirFeb 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