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Home » Biogen’s Timeframe for Aducanumab’s Confirmatory Trial Concerning to FDA
Biogen’s Timeframe for Aducanumab’s Confirmatory Trial Concerning to FDA
The FDA is worried that Biogen may take too long to complete a required confirmatory trial for Aduhelm (aducanumab), the high profile Alzheimer’s disease drug that just this week scored a historic FDA approval amidst doubts about its clinical trial data and criticisms of the agency’s close collaboration with Biogen.