FDA broke own protocols in approving Biogen Alzheimer’s drug, congressional report says

The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday. The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol.
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