Children who inherit genetic mutations from parents with early-onset Alzheimer’s typically show signs of dementia at the same ...

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 ...

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

Biogen does not undertake any obligation to publicly update any forward-looking statements. The Pharma Letter. 2024. BRIEF-Mexican approval for Alzheimer’s drug Leqembi. Available at ...

(Reuters) -The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly three months after it recommended approval for the drug to treat ...

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 ...

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 ...