The FDA asked Cytokinetics for the Risk Evaluation and Mitigation Strategy after it had already accepted the application for aficamten, a potential competitor to Bristol Myers Squibbs heart drug Camzyos. Analysts say this development could signal a change in FDA thinking about risk management for the broader drug class.
The post FDA Pushes Out Decision for Cytokinetics Heart Drug to Review Proposed Safety Plan appeared first on MedCity News.
