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Regulation

New Aduhelm label disregards Biogen’s call for diagnostic  

FDA isn’t requiring evidence of β-amyloid to prescribe the Alzheimer’s drug, a move that would mirror trials, avoid exposing misdiagnosed patients

FDA isn’t requiring evidence of β-amyloid to prescribe Biogen’s newly approved Alzheimer’s drug, a move that would mirror trials and avoid exposing misdiagnosed patients.

Jul 8, 2021 | 10:12 PM GMT

The revised Aduhelm label released Thursday calls for initiating therapy in early stage Alzheimer’s patients, which is consistent with clinical trial data and is in accord with statements from Biogen and Eisai. Unlike the clinical trials, and in contrast to recommendations from

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