The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

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

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

The global health landscape faces challenges and innovations, with the European review of Alzheimer's drug Leqembi, Ebola ...

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

Shares of BioArctic AB tumbled by 7% on Friday following news that the European Commission (EC) has requested further review of the company's Alzheimer's drug, lecanemab, by the Committee for ...

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 ...

Financial writer recommends Voyager Therapeutics, Inc. for high-risk investors due to promising preclinical Alzheimer's ...

These boards are cropping up around the US as neurologists acclimate to a new class of drugs, but not everyone agrees such ...

In this week’s edition of InnovationRx, we look at HHS nominee Robert F. Kennedy Jr.’s first Senate confirmation hearing, the ...

President Donald Trump signed the bipartisan Laken Riley Act into law as his administration’s first piece of legislation.

The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody ...