FDA sets June decision deadline for potential full approval, label expansion of Sarepta’s Duchenne gene therapy

Sarepta Therapeutics could soon notch another regulatory win.

Despite the company and its Duchenne gene therapy getting dogged by debate, and then a failed confirmatory study, the treatment appears headed for a label expansion that would broaden its use beyond boys ages 4 and 5.

On Friday, the company Click here to view original post

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