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

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

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

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 Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November ...

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

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

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

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.

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

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

A single course of newly approved Alzheimer's drug donanemab-azbt, the second medicine available in Japan targeting proteins in the brains of sufferers of the debilitating disease, will cost 3.08 ...