Analysis: U.S. FDA faces mounting criticism over Alzheimer’s drug approval

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By Deena Beasley and Julie Steenhuysen (Reuters) – In approving the first new Alzheimer’s drug in nearly 20 years, the U.S. Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say. The Biogen Inc drug, Aduhelm, was authorized based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slows progression of the lethal mind-wasting disease. The FDA has granted so-called “accelerated approval” in more than…

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