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

The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

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

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.

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

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

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...

Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...

Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...

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

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