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On 7 September, the US Food and Drug Administration (FDA)’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7 to 2 in favor of approval of Amylyx Pharmaceuticals’ oral drug AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The panel’s recommendation is not an official approval for the drug, this will come by 29 September. The vote reversed a previous recommendation by the same committee, which voted 6 to 4 against approval in March. AMX0035 was granted conditional approval in Canada in June, with Health Canada reviewing the decision once phase 3 trial results are released, expected in mid-2024. Amylyx co-founder Justin Klee has publicly pledged to voluntarily withdraw the drug from the US market if the larger trial does not produce positive results (his statement is non-binding).