Duchenne News Tags: Santhera

January 9, 2023
Santhera and ReveraGen Announce FDA Acceptance of New Drug  Application for Vamorolone in Duchenne Muscular Dystrophy
October 28, 2022
Santhera and ReveraGen submit NDA to FBA for vamorolone in treatment of Duchenne
October 6, 2022
Santhera Provides Updates on Submission of Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy
June 30, 2022
On June 29, 2022, Santhera announced that the clinical module of its rolling new drug application (NDA) for vamorolone in Duchenne muscular dystrophy has been submitted to the U.S. Food and Drug Administration (FDA).

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Complete applications due April 3, 2023.