The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...

Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

EU drugs regulator recommends approval of Leqembi for early Alzheimer's, pending European Commission acceptance, for specific ...

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.

Analysis of Leqembi's commercial potential and market outlook, with a focus on growth projections and investment ...

The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with ...

Longer-term, Eisai and Biogen are hoping for further evidence to support Leqembi from the phase 3 AHEAD 3-45 trial, which ...

The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...

Leqembi’s sales continue to be underwhelming, according to analysts, who contend the companies’ Alzheimer’s disease therapy ...

The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages ...

The European Union's drugs regulator has recommended approval for Eisai and Biogen's Alzheimer's drug Leqembi. This marks a ...