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

Investing.com -- Shares of BioArctic AB (STO:BIOA B) climbed 4.8% following the announcement of its partner Eisai's robust sales figures for Leqembi, which exceeded consensus estimates. The ...

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

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

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

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

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

An international clinical trial aimed at preventing Alzheimer’s disease (AD) in young adults who are at risk of developing ...

Cendakimab fell short of the bar. The antibody hits IL-13, one of the interleukins targeted by Regeneron and Sanofi’s blockbuster Dupixent. Last year, BMS reported a phase 3 trial in eosinophilic ...

Zimmer Biomet Announces Definitive Agreement to Acquire Paragon 28 This proposed transaction further diversifies Zimm ...

It seems Eisai and Biogen have another hurdle to jump over in their bid to get EU approval for their Alzheimer's disease therapy Leqembi. In the latest development, the European Commission has ...

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