MRK FDA calendar & decision history Merck · 2 upcoming · 14 past FDA decisions
Upcoming FDA catalysts MRK · Sep 21, 2026 FDA decision MRK · Oct 10, 2026 Ifinatamab deruxtecan (I-DXd) — Extensive-stage small cell lung cancer FDA decision history (14) Jul 10, 2026✓ Approved KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYN Jun 24, 2026✓ Approved Trodelvy (sacituzumab goviteca Jun 18, 2026✓ Approved CAPVAXIVE (Pneumococcal 21-val Jun 12, 2026✓ Approved KEYTRUDA (pembrolizumab) and K Apr 21, 2026✓ Approved IDVYNSO (doravirine/islatravir Feb 20, 2026✓ Approved FDA decision Feb 11, 2026✓ Approved KEYTRUDA and KEYTRUDA QLEX Dec 17, 2025✕ CRL FDA decision Nov 21, 2025✓ Approved FDA decision Oct 27, 2025✓ Approved FDA decision Sep 19, 2025✓ Approved FDA decision Jun 13, 2025✓ Approved FDA decision Jun 9, 2025✓ Approved FDA decision May 14, 2025✓ Approved FDA decision See the full 2026 PDUFA calendar → This page aggregates MRK's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.
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