The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

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 ...

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 ...

With thousands of press releases published each week, it can be difficult to keep up with everything on . To help healthcare ...

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 ...

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 ...

REGENXBIO is a longtime player in the gene therapy space, but one that’s yet to bring its own therapy to market (in the early ...