FDA does about-face on review of potential ALS treatment from Amylyx

FDA does about-face on review of potential ALS treatment from Amylyx

The Food and Drug Administration has reversed an internal decision and will now review an experimental treatment for amyotrophic lateral sclerosis — a victory for ALS patients and advocates who have been pressuring regulators to act with more urgency against the fatal, neurodegenerative disease. Amylyx Pharmaceuticals, a Cambridge, Mass.-based drug maker, said Wednesday that it will submit an application for its ALS treatment, called AMX0035, “in the coming months.” What is it? STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What's included? - Daily reporting and analysis - The most comprehensive industry coverage …
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