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FDA Investigates Gene Therapy Deaths Amid Calls for Resumption

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Source: fda.gov
FDA Investigates Gene Therapy Deaths Amid Calls for Resumption
Photo: fda.gov
TL;DR

The FDA recommends lifting the voluntary hold on Elevidys for ambulatory patients with Duchenne Muscular Dystrophy after concluding that a recent death was unrelated to the therapy, while ongoing concerns for non-ambulatory patients remain under review.

Topics:businesshealth#duchenne-muscular-dystrophy#elevidys#fda#gene-therapy#health#safety
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  1. FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients  fda.gov
  2. Why Sarepta may not survive its current gene therapy crisis  statnews.com
  3. FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault  Fierce Pharma
  4. Two boys died after a gene therapy. This family won’t give up hope.  The Washington Post
  5. Parents urge FDA to restore gene therapy after distribution pause  NewsNation

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