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)

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Santhera Submits Marketing Authorization Application to the UK MHRA for Vamorolone in Duchenne Muscular Dystrophy

Pratteln, Switzerland, March 2, 2023
Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

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