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 ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

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

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

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two ...

Japanese pharmaceutical company Eisai Co and U.S. firm Biogen Inc said Monday that a jointly developed Alzheimer's drug has been approved for continuous use for people with early stages of the disease ...

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

TOKYO -- Japanese drugmaker Eisai will make its Alzheimer's disease treatment Leqembi available for at-home administration by ...

The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...

Biogen (BIIB) and Eisai announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...