BreakingApprovals

Camzyos's Sept 30 Adolescent PDUFA Does Not Rewrite Adult REMS or Age-18 PA Gates

FDA set a Sept 30 PDUFA for Camzyos in adolescent oHCM. We analyze SCOUT-HCM data, adult SPL lag, FEP Blue's age-18 PA, and restricted REMS operations.

PHOTO ILLUSTRATION · PHARMADOSSIER

By Ran Chen·Updated September 2, 2026·29 min read

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