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

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

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) ...

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 ...

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

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

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 ...

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 ...

The article provides an overview of recent developments in the healthcare sector, including Novo Nordisk's phase-out of ...

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

The first drug targeting the root cause of Alzheimer’s disease has been approved by the European Medicines Agency. Despite ...