Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ALS approved in Canada since 2018
ALBRIOZA (also known as AMX0035) is an oral fixed-dose
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The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals (NASDAQ: AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).
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Turning Point Therapeutics, Inc. (NASDAQ: TPTX) shares jumped 115.8% to $73.72 after Bristol Myers Squibb announced it will acquire Turning Point Therapeutics for $76 per share.