FDA Grants Priority Review to ALS Therapy AMX0035

FDA Grants Priority Review to ALS Therapy AMX0035

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FDA Grants Priority Review to ALS Therapy AMX0035

The U.S. Food and Drug Administration (FDA) has accepted for review Amylyx Pharmaceuticals‘ application seeking approval of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The new drug application (NDA) also was granted priority review by the regulatory agency, which reduces review time from the standard 10 months to six months. A decision by the FDA is expected by June 29. Meanwhile, the agency is planning to hold an advisory committee meeting to discuss…

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