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 ...

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

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

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

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

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

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

Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...

The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...

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 is seeking approval for an injectable version of Leqembi while Eli Lilly is developing a new injectable drug. These ...