PHOENIX

FDA, Amylyx Meeting to Review AMX0035 for Possible Approval

A U.S. Food and Drug Administration (FDA) advisory committee has scheduled a virtual meeting with Amylyx Pharmaceuticals to review its application for the approval of AMX0035 to treat amyotrophic lateral sclerosis (ALS), the company announced. The online meeting to discuss data supporting the approval request is set for March 30.

Canadian Registry, Amylyx Working to Collect Real-life Data on AMX0035

The Canadian Neuromuscular Disease Registry (CNDR) and Amylyx Pharmaceuticals are collaborating on an initiative that could produce the first real-world evidence on AMX0035, Amylyx’s investigational therapy to slow functional decline in amyotrophic lateral sclerosis (ALS) patients. The two, in partnership with neuromuscular centers across Canada, will collect…