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Biogen rises as FDA panel backs Alzheimer s drug, easing safety concerns

Shares of Biogen Inc rose 4% in premarket trade on Monday as an unanimous backing of the company s Alzheimer s drug Leqembi by the U.S. regulator s advisers eased concerns that a traditional approval. | June 12, 2023

Biogen : Stock Trading Halted Today; FDA Advisory Committee to Review Supplemental Biologics License Application for the Potential Traditional Approval of LEQEMBI in Early Alzheimer s Disease

US FDA panel back traditional approval for Eisai-Biogen s Alzheimer s drug Leqembi

A panel of expert advisers on Friday unanimously agreed that a late-stage clinical trial of Eisai and Biogen s Leqembi verified the benefit of the treatment for Alzheimer s disease, clearing the way. | June 9, 2023

FDA staff say Eisai s Alzheimer s drug may get full approval despite concerns

Staff reviewers of the U.S. Food and Drug Administration said on Wednesday that Eisai and Biogen s Alzheimer s drug, Leqembi, may still be eligible for a full approval despite concerns of. | June 7, 2023

FDA staff say Eisai s Alzheimer s drug can get full approval despite safety concerns

Staff reviewers of the U.S. drug regulator said trial data on Eisai and Biogen s Leqembi confirmed benefits of the early Alzheimer s drug and the prospects of a full approval were unaffected by higher. | June 7, 2023

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