REGN FDA calendar & decision history Regeneron Pharmaceuticals Inc. · 2 upcoming · 13 past FDA decisions
Upcoming FDA catalysts REGN · Aug 31, 2026 Garetosmab - (OPTIMA) — Fibrodysplasia Ossificans Progressiva (FOP) REGN · Nov 30, 2026 Cemdisiran + pozelimab (C5 combo) - (NIMBLE) — Generalized myasthenia gravis (gMG) FDA decision history (13) Apr 23, 2026✓ Approved Otarmeni (lunsotogene parvec-c Apr 22, 2026✓ Approved DUPIXENT (dupilumab) - (LIBERT Apr 2, 2026✓ Approved EYLEA HD (aflibercept) - (PHOT Feb 24, 2026✓ Approved FDA decision Nov 19, 2025✓ Approved FDA decision Oct 17, 2025✕ CRL FDA decision Oct 8, 2025✓ Approved FDA decision Jul 30, 2025✕ CRL FDA decision Jul 2, 2025✓ Approved FDA decision Jun 2, 2025✓ Approved FDA decision May 23, 2025✕ CRL FDA decision Apr 20, 2025✕ CRL FDA decision Apr 18, 2025✓ Approved FDA decision See the full 2026 PDUFA calendar → This page aggregates REGN'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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