The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly ...

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 ...

European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for ...

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 ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer'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 ...

The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.

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 ...