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REGN FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET

REGN has 1 upcoming FDA decision date; the nearest is Nov 2026 for Cemdisiran (C5 RNAi) - (NIMBLE). 14 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.

REGN catalyst hub · full calendar

Upcoming

Nov 2026 Cemdisiran (C5 RNAi) - (NIMBLE)

Decided

Aug 19, 2026 ✓ ApprovedPasatru (garetosmab-grts)Apr 23, 2026 ✓ ApprovedOtarmeni (lunsotogene parvec-cwha)Apr 22, 2026 ✓ ApprovedDUPIXENT (dupilumab)Apr 2, 2026 ✓ ApprovedEYLEA HD (aflibercept)Feb 24, 2026 ✓ Approvedprice-onlyNov 19, 2025 ✓ ApprovedEYLEA HDOct 17, 2025 CRLSolnerstotugOct 8, 2025 ✓ ApprovedLibtayoJul 30, 2025 CRLprice-onlyJul 2, 2025 ✓ ApprovedLynozyficJun 2, 2025 ✓ Approvedprice-onlyMay 23, 2025 CRLprice-onlyApr 20, 2025 CRLEYLEA HDApr 18, 2025 ✓ ApprovedDupixent