Santhera, ReveraGen Advancing Plans for Vamorolone Application

Santhera, ReveraGen Advancing Plans for Vamorolone Application

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Santhera, ReveraGen Advancing Plans for Vamorolone Application

Santhera Pharmaceuticals and ReveraGen BioPharma are gearing up to submit a new drug application (NDA) asking for U.S. approval of vamorolone as a treatment for Duchenne muscular dystrophy (DMD). The companies announced Tuesday they had completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA). In the meeting, the FDA indicated that results from the recently finished pivotal portion of the VISION-DMD clinical trial provide sufficient safety and efficacy data to support an NDA.…

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