FDA de­lays its de­ci­sion on Bris­tol My­er­s' $13B heart drug an­oth­er three months

Last week, Bris­tol My­ers Squibb marched out long-term da­ta for its heart drug mava­camten ahead of what ex­ecs had hoped would be a pos­i­tive FDA de­ci­sion in Jan­u­ary. But reg­u­la­tors are say­ing they need a bit more time to think.

The FDA has ex­tend­ed mava­camten’s PDU­FA date three months, from Jan. 28 to April 28, Bris­tol My­ers an­nounced on Fri­day. The news came just a few days af­ter in­de­pen­dent drug pric­ing watch­dog ICER raised con­cerns about the can­di­date’s long-term safe­ty in its fi­nal ev­i­dence re­port.

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