STAT+: FDA, under fire from critics, revises prescribing information for Biogen’s Alzheimer’s drug

The Food and Drug Administration on Thursday changed the prescribing label for Biogen’s Alzheimer’s treatment Aduhelm — narrowing its recommended use to patients with milder forms of the disease.

Biogen and the FDA described the Aduhelm label update as a clarification meant to better reflect data from clinical trials. But the move will also be seen as the FDA yielding to outside criticism that the drug’s approval — just one month ago — was overly permissive.

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