FDA Pushes Potential Approval For Cytokinetics' Experimental Heart Drug By Three Months
The U.S. Food and Drug Administration (FDA) on Thursday extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for Cytokinetics Inc's CYTK aficamten for patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26 from September 26.The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company's proposed Risk Evaluation and Mitigation Strategy (REMS).Also Read: Bristol Myers Analyst Says FDA Update Is ...