FDA advisory panel narrowly approves Sarepta's Duchenne gene therapy for accelerated approval
TL;DR
An FDA advisory committee voted 8-6 in favor of accelerated approval of Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, known as SRP-9001, based on a surrogate endpoint for patients who are able to walk and have a confirmed mutation.
Topics:businesshealthcare#accelerated-approval#duchenne-muscular-dystrophy#fda#gene-therapy#healthcare#sarepta-therapeutics
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