FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

4 months ago 48

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. Peter Marks, the agency’s top biologics official, reviewed the same data and reached a different conclusion. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.


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