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

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.

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

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

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

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

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

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

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

In the world of health, Novo Nordisk stops insulin pen production, Trump's potential health appointments draw attention, and ...

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

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