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FDA Official Intervenes in Sarepta Therapy Dispute, Upcoming Advisory Committee Meetings Announced

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Source: STAT
FDA Official Intervenes in Sarepta Therapy Dispute, Upcoming Advisory Committee Meetings Announced
Photo: STAT
TL;DR

FDA staff were leaning towards rejecting Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, but a top official, Peter Marks, intervened and directed staff to schedule a public hearing on the therapy. Marks is a vocal advocate for faster gene therapy approvals.

Topics:businesshealth#duchenne-muscular-dystrophy#fda#gene-therapy#health#peter-marks#sarepta-therapeutics
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  1. With FDA staff opposed to Sarepta therapy, top official intervened  STAT
  2. Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting Announcement - 05/12/2023  FDA.gov
  3. Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement - 05/18/2023  FDA.gov
  4. View Full Coverage on Google News

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