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The accelerated approval for Eisai and Biogens Leqembi (lecanemab) was converted to a full approval based on results from the confirmatory Clarity-AD trial, which the FDA said in its statement verified the drugs benefit

Guo X, Zhou L, Wang Y, Suo F, Wang C, Zhou W, et al

Healthcare providers may consider using standardized screening tools such as the PHQ-9 (Patient Health Questionnaire-9) to monitor for depression symptoms during follow-up visits, particularly for patients with pre-existing mental health conditions

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