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 ...

The global health landscape faces challenges and innovations, with the European review of Alzheimer's drug Leqembi, Ebola ...

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 ...

Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) are expected to face another delay in launching their new Alzheimer's drug, lecanemab, in the EU after the European Commission on Friday asked the region's ...

With thousands of press releases published each week, it can be difficult to keep up with everything on . To help healthcare journalists and consumers stay on top of the week's most newsworthy and ...

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 ...

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

In this week’s edition of InnovationRx, we look at HHS nominee Robert F. Kennedy Jr.’s first Senate confirmation hearing, the ...

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