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.

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

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

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 ...

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 ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

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 ...

In an exclusive interview in Amsterdam with EURACTIV’s partner EFE, Emer Cooke, the executive director of the European Medicines Agency (EMA), stressed that Europeans are much “better ...

EMA's CHMP issued a positive opinion for Novartis ... with generally low-grade symptomatic adverse events. The European Commission (EC) will decide in approximately two months.

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