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 US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...
Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...
With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.