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

The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...

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

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

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 ...

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...

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