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

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

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 ...

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

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

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 ...

Michael Yee has given his Buy rating due to a combination of factors including the recent positive developments regarding Biogen’s Alzheimer’s drug, Leqembi, in the European market. The European ...

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 ...

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...

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