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 ...

The European Commission has for the first time approved an Alzheimer's therapy that targets the underlying disease processes.

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

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 ...

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

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.

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

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 ...