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

Why one trial participant's healthy birth after her CAR-T treatment for lupus is catching resesarchers' attention: ...

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

Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys ...

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 ...

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.

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.

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

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

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