Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's radiopharmaceutical sector, according to the European Medicines Agency (EMA). Vi ...

The European Commission said Wednesday that it had given formal approval for Leqembi, a long-awaited new treatment for ...

Cullinan Therapeutics (CGEM) announced that the European Medicines Agency, EMA, approved the Company’s Clinical Trial Application, CTA, for ...

The ESMP is integrated with the European Medicines Agency’s (EMA) data management services to ensure a reliable exchange of information. The upcoming second version will enable MAHs and NCAs to ...

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 ...

More ‘biosimilar’ medicines should be brought to market in the EU because of a regulatory policy shift on the need to carry out expensive clinical efficacy studies, experts have said.

Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi ...

Sarepta and Roche paused Elevidys trials in the EU after a patient death. Analysts warn of potential sales declines as safety ...

Roche (RHHBY) sent a letter dated March 31 to the World Duchenne Organization stating the European Medicines Agency requested a temporary ...

Weight loss drugs such as semaglutide, found in Ozempic and Wegovy, are tied to a 40% reduced risk of an Alzheimer's disease diagnosis. On Wednesday, a study in Nature suggested that a vaccine for ...

representatives of the European Medicines Agency (EMA), other regulatory agencies, and European agencies for Health Technology Assessment (HTA; including IQWiG) held several workshops in the ...