The warning comes amid reports that unregulated therapies are being offered directly to patients, potentially illegally. View ...

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 ...

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 Medicines Agency (EMA) gave its approval to an artificial intelligence diagnostic tool for the first time on ...

The European Medicines Agency provides an interactive map with data from the information system for clinical trials. This is ...

The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European ...

AI-powered digital pathology specialist PathAI, based in Boston in the US, said that AIM-NASH AI Assist is designed to assist ...

To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations, and clinical trial regulations.

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 ...