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

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

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

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) ...

US regulators approved Leqembi in 2023 and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved the ...

The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval ...

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

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

Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease, reversing an earlier decision not to give it the green light.

The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...

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.

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