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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.

Biogen Inc.’s BIIB Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal ...

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 ...

That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.

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

The EMA 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 ...

Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...

The EU's drugs regulator has recommended approval for Leqembi, a treatment by Eisai and Biogen, for early Alzheimer's disease ...