FDA is critical of data on Amylyx ALS drug, but cites ‘regulatory flexibility’
[ad_1] Results from a single clinical trial of an experimental drug for ALS developed by Amylyx Pharmaceuticals “may not be sufficiently persuasive” to support approval, according to a review of the drug posted Monday by officials with the Food and Drug Administration. Reviewers in the FDA’s Office of Neuroscience criticized the data, which showed the…

