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

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

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

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's ...

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 monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...

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

The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...

The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...

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

A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research ...

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