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ALS Association Calls On FDA To Follow The Lead Of Canadian And European Counterparts In Expediting Access To Promising New Treatment
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WASHINGTON, April 14, 2021 /PRNewswire/ Following the lack of action by the FDA to expedite approval of AMX0035, an experimental treatment for ALS, The ALS Association today called on the agency to follow its own guidance and move with the urgency of its Canadian and European Union counterparts. Health Canada and the European Medicines Agency (EMA) are working with Amylyx, the company that makes AMX0035, to move the treatment toward approval.