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 ...

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.

At present, the use of NAMs in regulatory submissions to the European Medicines Agency (EMA) is limited. This is owing to barriers such as developers' caution in sharing NAM data with regulators ...

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 ...

A new international study reveals a possible connection between GLP1 receptor agonists—used in drugs like Ozempic—and ...

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 ...

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

The pharmaceutical industry faces environmental challenges. Green chemistry offers sustainable solutions to reduce waste and enhance drug discovery processes.

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 ...

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11 ...