Archives for September 11, 2020

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FDA calls for more data on Sarepta gene therapy for DMD

FDA calls for more data on Sarepta gene therapy for DMD

By Jane Byrne

An FDA regulatory request to Sarepta could delay the timeline for approval of its Duchenne muscular dystrophy (DMD) gene therapy if it results in a deferral of the start of a planned Phase 3 study for SRP-9001.