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

Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...

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

The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.

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

Children who inherit genetic mutations from parents with early-onset Alzheimer’s typically show signs of dementia at the same ...

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

Novartis issued stronger guidance than Wall Street expected. Elsewhere, Eisai and Biogen’s Alzheimer’s drug will get a closer ...

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 ...