News

Vamorolone NDA mid-cycle review meeting by FDA completed

Pratteln, Switzerland, and Rockville, MD, USA, April 25, 2023
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the U.S. Food and Drug Administration (FDA) of the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).