Amylyx Seeks U.S. Approval of AMX0035 With FDA Filing

Amylyx Seeks U.S. Approval of AMX0035 With FDA Filing

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Amylyx Seeks U.S. Approval of AMX0035 With FDA Filing

Amylyx Pharmaceuticals is seeking approval in the U.S. for AMX0035, its investigational therapy for slowing functional decline in people with amyotrophic lateral sclerosis (ALS). The company submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory review. The decision had been announced last month following recent discussions with the FDA. The agency had previously requested data from a large Phase 3 clinical trial before considering AMX0035 for approval. “We are…

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