Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...

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

"After re-examining its initial opinion, the EMA... has recommended granting marketing authorisation to Leqembi (lecanemab) ...

The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...

NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (" NurExone " or the " Company "), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce ...

The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for Alvotech and Advanz Pharma’s ...

Relocating the EMA before March 2019 will therefore ... procedure and appointment of professor Guido Rasi as the European Medicines Agency’s executive director in 2011. Rasi had to step down ...

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing ...

Aurobindo Pharma's Hyderabad-based biosimilars facility receives GMP certification from the European Medicines Agency, paving ...

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 ...

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...

CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...