The US Food and Drug Administration is relying on enhanced pharmacovigilance and a label warning to address one of the safety concerns that Sarepta Therapeutics Inc. said delayed approval of its Duchenne muscular dystrophy drug Vyondys 53 (golodirsen).
Golodirsen received accelerated approval 12 December for patients with a confirmed mutation of the DMD gene that is amenable to...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet 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
Already a subscriber?