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 ...

The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

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 ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

Eisai and Biogen announced FDA approval for LEQEMBI’s once every four weeks maintenance dosing for Alzheimer’s disease treatment. Eisai Co., Ltd. and Biogen Inc. announced that the U.S. FDA ...

The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...

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.

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatmentAlzheimer's disease progression does ...

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 ...