STAT+: Canada approves ALS drug from Amylyx Pharma as U.S. patients await extended review

Amylyx Pharmaceuticals secured approval in Canada on Monday for a new medicine to treat patients with ALS — the same drug that has faced skepticism from regulators in the U.S., where an approval decision is expected in September.

The drug, called Albrioza, is the first new therapy approved for ALS in Canada since 2018. The medicine is also the first to be approved from Amylyx, based in Cambridge, Mass.

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