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Congressional Probe of Alzheimer’s Drug Approval Finds Fault With FDA Actions

The FDA broke with its own protocols in reviewing and subsequently approving Alzheimer’s drug aducanumab (Aduhelm), by inappropriately collaborating with drugmaker Biogen on briefing documents, holding unreported meetings, and failing to gain internal consensus before engaging in such collaborations, according to an in-depth congressional investigation of the interactions between the agency and the drugmaker. The […]

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