Posted by Michael Wonder on 29 Jun 2023
Italfarmaco Group completes FDA submission of new drug application for givinostat in Duchenne muscular dystrophy and receives priority review
29 June 2023 - Submission based on completed Phase 3 program in 179 boys demonstrating significant slowing of disease progression with a good safety and tolerability profile.
Italfarmaco announced today that the US FDA has completed its filing review and accepted the company’s new drug application for givinostat.
