The EMA's human medicines committee has said it cannot approve Biogen and Eisai's Alzheimer's disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug.
Biogen and Eisai have said that the EMA's human medicines committee looks unlikely recommended approval of their Alzheimer's drug Aduhelm when it comes up for discussion next month.
The EMA's human medicines committee has recommended approval of Roche's Ronapreve and Celltrion's Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to be bac
Danish drugmaker Novo Nordisk is hoping to launch its once-weekly injectable treatment for obesity, Wegovy, in the EU next year after getting a green light from the EMA's human medicines co
The EMA has given the go-ahead to the use of Pfizer and BioNTech's COVID-19 vaccine Comirnaty as a booster for all people aged 18 or more, but says EU member states must decide for themselv
Any lingering hope that Pfizer may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after the EMA's human medicines committe