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FDA reviewers had string of concerns about Sarepta’s gene therapy for Duchenne, documents show

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statnews.com/2023/05/10/fda-reviewers-had-string-of-concerns-about-sareptas-gene-therapy-for-duchenne-documents-show

FDA reviewers had string of concerns about Sarepta’s gene therapy for Duchenne, documents show
Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday.
The FDA documents,…

This story from statnews.com was posted on 2023-05-10 by @birdsky.

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