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

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

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

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

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 ...

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

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

IV Maintenance Dosing for the treatment of Early Alzheimer's Disease Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...