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 ...

Shares of BioArctic AB tumbled by 7% on Friday following news that the European Commission (EC) has requested further review of the company's Alzheimer's drug, lecanemab, by the Committee 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 Inc. (NASDAQ:BIIB), a leading biopharmaceutical company specializing in neurology and rare diseases, finds itself at a critical juncture as it navigates a complex landscape of opportunities and ...

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 ...

The FDA approved a monthly maintenance dosing of intravenous lecanemab (Leqembi) for early Alzheimer's disease, said ...