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Tag: accelerated review


Cell and Gene Therapy, Industry

Sarepta asks FDA to approve first gene therapy for Duchenne muscular dystrophy

September 29, 2022

Via: Biopharma Dive

Sarepta Therapeutics has asked the Food and Drug Administration to approve its gene therapy for Duchenne muscular dystrophy under accelerated review, the company said Thursday. The biotechnology company‚Äôs application for SRP-9001, also known as delandistrogene moxeparvovec, is primarily based on […]