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FDA Advisory Panel Narrowly Votes Against New ALS Drug

In a close vote, an advisory panel for the U.S. Food and Drug Administration decided not to recommend the approval of an experimental drug for the deadly neurological disease amyotrophic lateral sclerosis (ALS).

The panel’s decision had been closely watched, with patient advocacy groups lobbying hard for fast-track approval.

However, on Wednesday the panel ruled 6-4 that data from a single, mid-stage study sponsored by Amylyx Pharmaceuticals was not enough to prove the company’s drug makes a meaningful difference in patients’ lives.