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New memos show how top FDA officials thought slim evidence was enough for Alzheimer drug approval

FDA statisticians did not believe experimental Alzheimer's treatment Aduhelm proved that it could slow down the cognitive disease, but the top brass at the agency thought there was enough evidence to approve the drug anyway, according to internal documents released by the FDA today.

Why it matters: Outside experts almost unanimously voted down the drug, and the scientific community has blasted the FDA's approval of Aduhelm. But FDA leaders repeatedly cited "the urgent and unmet medical need" for Alzheimer's treatments.

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