Scrutiny of safety plan extends FDA’s review of BMS heart therapy

FDA’s extended review of an updated REMS for BMS’s cardiomyopathy therapy mavacamten will further delay a launch that the pharma had hoped could come as soon as this year, based on the timeline BMS had projected when it acquired MyoKardia for $13.1 billion.

Bristol Myers Squibb Co. (NYSE:BMY) said Friday that FDA has added three months to the timeline, granting a new PDUFA date of April 28, 2022. The pharma said FDA is seeking “to allow sufficient time to review information pertaining to updates” to the REMS that BMS had proposed upon submission...