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FDA Grants Full Approval For Alzheimer's Drug, Despite Concerns

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The Food and Drug Administration granted full approval for Biogen and Eisai’s anti-Alzheimer’s drug lecanemab, the first of its kind to slow Alzheimer’s Disease, just six months after it received accelerated approval, though experts have expressed concern over severe and potentially fatal side effects of the drug.Key Facts

Lecanemab, which is made by Biogen and Japanese drugmaker Eisai, received full approval after the FDA determined through a series of trials it has a “verified clinical benefit,” the agency announced in a statement, making the drug the first Alzheimer’s treatment with full approval through the FDA.

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