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

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 ...

An international clinical trial aimed at preventing Alzheimer’s disease (AD) in young adults who are at risk of developing ...

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 ...

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 ...

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

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 ...

(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 ...

Learn more about whether Biogen Inc. or Neurocrine Biosciences, Inc. is a better investment based on AAII's A+ Investor grades, which compare both companies' key financial metrics.