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

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

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.

BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai ...

1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...

Intercept’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...

As of Oct. 31, Zevra has received 90 prescription enrollment forms for MIPLYFFA of which 30% are approved ... MIPLYFFA was further granted Orphan Medicinal Product designation by the European ...

In addition, we have completed marketing authorization application (MAA) submissions for sebetralstat to the European ...

EBR Systems is among ASX healthcare stocks with upcoming catalysts, expecting feedback on a FDA substantive review expected ...

Encouraging results from Phase 1/2 study of mirdametinib in pediatric patients with low-grade glioma also to be presented in oral session at SNO – STAMFORD, Conn., (GLOBE NEWSWIRE) -- SpringWorks ...

Under the terms of the proposed agreement, Pluri will provide GMP-compliant manufacturing of NurOwn at its facilities in Israel. This collaboration aims to fulfill essential supply requirements of ...

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company advancing ...