Posted by Michael Wonder on 09 Jan 2023
Santhera and ReveraGen announce FDA acceptance of new drug application for vamorolone in Duchenne muscular dystrophy
9 January 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce that the US FDA has accepted the new drug application for vamorolone for the treatment of Duchenne muscular dystrophy for filing.
The FDA has set 26 October 2023 as the Prescription Drug User Fee Act (PDUFA) target action date.
