Posted by Michael Wonder on 01 Nov 2022
European Medicines Agency validates Santhera’s marketing authorisation application for vamorolone in Duchenne muscular dystrophy
31 October 2022 - Santhera Pharmaceuticals announces that the EMA has validated its marketing authorisation application for vamorolone for the treatment of Duchenne muscular dystrophy.
Santhera expects the CHMP to complete the review and issue an opinion regarding approval to EMA’s European Commission in late Q3-2023.
