Posted by Michael Wonder on 27 Oct 2022
Santhera and ReveraGen complete NDA submission to FDA for vamorolone in Duchenne muscular dystrophy
27 October 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce that they have completed the rolling submission of a new drug application to the US FDA, seeking priority review for vamorolone for the treatment of Duchenne muscular dystrophy.
Subject to approval, vamorolone is set to become available to patients in the US in H2, 2023.
