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

Research supporting the amyloid hypothesis—the idea that Alzheimer's is caused by a buildup of amyloid plaques in 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.

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

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

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

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

The Washington University trial comes as part of a larger platform study which hopes to understand if Alzheimer's disease can ...

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

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...