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Biogen Gets ‘Almost Shockingly Broad’ Label For Alzheimer’s Drug Aducanumab

Executive Summary

US FDA’s Peter Stein says drug’s mechanism of action is relevant to all stages of Alzheimer’s disease. While clinical trials enrolled only those with mild disease as indicated on a PET scan, labeling has no limitations on use of Aduhelm. An FDA advisory committee member resigns from the panel in response to the approval.

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