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 ...

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

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

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

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

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

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 ...

BioArctic AB (BRCTF) reports significant royalty growth and strategic advancements amid revenue challenges and rising R&D expenses.

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 ...