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

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

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

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 have hit another bump in their quest to win European regulatory approval of their Alzheimer's drug Leqembi. The companies on Friday said the European Commission has asked the ...

The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.

Eisai and Biogen announced FDA approval for LEQEMBI’s once every four weeks maintenance dosing for Alzheimer’s disease treatment. Eisai Co., Ltd. and Biogen Inc. announced that the U.S. FDA ...

Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing ...