Surprise As FDA Approves Sarepta’s Duchenne Drug Vyondys 53

A Second Controversial Duchenne Approval For Company

The FDA has overcome doubts about the drug's safety and reversed its decision in just four months.

FDAEntrance_1200x675
The approval went through the newly reorganized FDA Office of New Drugs

Sarepta Therapeutics Inc.‘s Duchenne muscular dystrophy therapy Vyondys 53 (golodirsen) has been approved by the US Food and Drug Administration in a surprise reversal of a rejection based on safety concerns.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

More from Scrip