3 results

• FDA Reviewing Elevidys Black Box Warning About Acute Liver Injury Risk

  November 17, 2025

  Michael Adams

  Following the FDA’s July 2025 request to stop Elevidys shipments, federal regulators are now evaluating a potential black box warning for Elevidys after at least three patient deaths were linked to the Duchenne muscular dystrophy treatment.

• Elevidys Liver Failure Risks Added to FDA Black Box Warning

  July 24, 2025

  Michael Adams

  The FDA issued a black box warning for the Duchenne muscular dystrophy gene therapy Elevidys after three patients died from acute liver failure linked to the treatment.

• Elevidys Side Effects Suspected in Liver Failure, Death of Duchenne Muscular Dystrophy Patient

  March 21, 2025

  Michael Adams

  Two years after its controversial FDA approval, the gene therapy treatment Elevidys has been linked to the death of a 16-year-old boy, reigniting debates over the drug's safety and the rigorousness of its approval process.