Mitsubishi Tanabe's ALS drug wins nod ahead of PDUFA date
By Jennifer Boggs
Managing Editor
Managing Editor
Monday, May 8, 2017
The FDA has joined Japanese and South Korean regulators in approving edaravone, an intravenously administered antioxidant free radical scavenger, for treating ALS, with its late Friday approval coming more than a month ahead of the PDUFA date.
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