The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European ...
A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not been formally approved and that millions have therefore been vaccinated ...
At its March meeting, the European Medicines Agency’s management board adopted the EMA’s annual report for 2024. This ...
In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint ...
The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's ...
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s ...
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...
of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ ®, Valneva’s single-dose vaccine for the prevention of disease caused ...