How an unproven Alzheimer’s drug got approved

New York Times

19 July 2021 - Though some of its own senior officials said there was little evidence of benefit for patients, the FDA nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.

Two months before the FDA’s deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug, aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation