Amylyx asks FDA to approve ALS drug, while also preparing late-stage study

Amylyx Pharmaceuticals has officially asked the Food and Drug Administration to approve its experimental and closely watched medicine for ALS.

Now, the FDA has around two months to decide whether Amylyx's application has all the necessary components. If so, the submission will be accepted and reviewed, a process which usually takes about 10 months before the agency issues a verdict.