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FDA delays decision date on Cytokinetics' heart drug to year-end in unusual safety program back-and-forth

on May 02, 2025

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FDA Delays Cytokinetics' Heart Drug Decision to December 2025

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Cytokinetics Deferred Evaluation Extension Hypertrophic obstructive cardiomyopathy Mitigation Strategy oHCM PDUFA Regulatory Setback REMS Risk United States Food and Drug Administration

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