Sarepta’s DMD Gene Therapy: FDA Says Concluding Effectiveness Or Ineffectiveness Is ‘Challenging’

 
• By Derrick Gingery
Gene therapy
The FDA said that Sarepta's commercial manufacturing process was not comparable to the process used to make SRP-9001 for early clinical studies. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers