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

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

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

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee ...

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 ...

Despite the regulatory setback, BioArctic's partner Eisai has stated that the safety profile of lecanemab reported in clinical practice in the United States, Japan, and other countries is consistent ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...

These boards are cropping up around the US as neurologists acclimate to a new class of drugs, but not everyone agrees such ...

This article highlights recent developments in healthcare, including the U.S. FDA's approval of Alzheimer's and diabetes ...

The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody ...

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once ...