STAT+: FDA advisory panel narrowly recommends approval for Sarepta’s gene therapy for Duchenne

A panel of independent advisers to the FDA narrowly voted 8 to 6 to recommend accelerated approval for Sarepta’s gene therapy for Duchenne muscular dystrophy.

May 13, 2023 - 20:00
STAT+: FDA advisory panel narrowly recommends approval for Sarepta’s gene therapy for Duchenne

For an archived version of a live blog about Friday’s FDA advisory panel hearing, click here.

A panel of independent advisers to the Food and Drug Administration narrowly voted 8-6 to recommend accelerated approval for Sarepta’s gene therapy for Duchenne muscular dystrophy, ruling that the potential benefit to patients outweighs a long list of concerns from the agency’s reviewers.

Continue to STAT+ to read the full story…

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