The European Medicines Agency (EMA) has agreed to review a marketing authorization application (MAA) from Amylyx Pharmaceuticals requesting the approval of AMX0035 — a combination of two compounds — for the treatment of people with amyotrophic lateral sclerosis (ALS). The validation comes nearly two months after Amylyx filed the…
Amylyx Pharmaceuticals has filed an application with the European Medicines Agency seeking the approval of its lead candidate AMX0035 as a treatment of amyotrophic lateral sclerosis (ALS), the company announced in a press release. The marketing authorization request follows similar submissions to Health Canada and…
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…
