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FDA delays decision on Sarepta’s controversial gene therapy for muscular dystrophy

Por: The Boston Globe Business May 24, 2023

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The Food and Drug Administration is delaying by one month its long-awaited decision on whether to approve a gene therapy for a deadly inherited muscle-wasting disease that afflicts more than 10,000 boys and young men nationwide, according to the Cambridge biotech that developed the medicine.Sarepta Therapeutics said Wednesday that after discussions with the FDA, the agency has postponed until June 22 its deadline for deciding whether to give... + full article



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