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 ...

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A trusted partner to 19 of the top 20 pharmaceutical companies, Medidata continues to break ground with new categories of critical patient-centric experiences, seamlessly integrating AI into its suite ...

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 ...