The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.
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Biogen Stock Down on Regulatory Update in the EU for Alzheimer's DrugThe EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...
The Washington University trial comes as part of a larger platform study which hopes to understand if Alzheimer's disease can ...
In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...
Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...
The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
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