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Sarepta Therapeutics Announces U.S. FDA Acceptance of an Efficacy Supplement to Expand the ELEVIDYS Indication
The FDA will make a decision whether or not to grant full approval of Sarepta’s gene therapy, Elevidys, by June 21,2024. The Efficacy Supplement submitted by Sarepta seeks to broaden the indication for Elevidys to all ages and irrespective of ambulation status.
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