In a landmark approval decision . . .

FDA Bucks Advisers, Approves Biogen’s Controversial Alzheimer’s Drug

By Beth Wang / June 7, 2021 at 12:54 PM
FDA on Monday (June 7) approved Biogen’s Alzheimer’s drug Aduhelm (aducanumab) after months of contentious debate during which the agency’s own advisers spoke out against approving the drug, while patients and patient advocates pushed for approval. The agency acknowledged the data underlying the decision weren’t straightforward but concluded the drug’s benefits outweigh its risks, and it opted to use the accelerated approval pathway to provide patients quick access to the first novel therapy approved for Alzheimer’s disease since 2003. As...

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