The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...

The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

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

Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.

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

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 ...

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

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 ...

Angle (LON:AGL) is a small share that's skyrocketed in recent weeks. Why does this investor hold the high-risk penny stock?

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...

(RTTNews) - Biogen Inc. (BIIB), a biotechnology company and Eisai Co., Ltd. On Friday provided an update on the regulatory review of lecanemab as a treatment for early Alzheimer's disease or AD in ...