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 ...

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

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 ...

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

EMA's human medicines committee issued positive recommendations for multiple drugs, including Merck's Keytruda and InflaRx's ...

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

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

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 ...

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