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

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

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.

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

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

Eisai Europe Ltd. and Biogen Inc. announced today that a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...

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

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...

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

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...

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

The European Medicines Agency has flipped its stance on Eisai and Biogen’s Alzheimer’s treatment Leqembi, recommending ...