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

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

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

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) ...

The firm said Biogen partner Eisai’s request for the EMA’s CHMP to reexamine the MAA for lecanemab in amyloid-positive early Alzheimer’s disease has paid off with a positive recommendation that ...

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

TOKYO, Nov 15, 2024 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Japan Ltd announced today that a TV commercial will be ...

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

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 ...

If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the ...