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 ...

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 Commission has for the first time approved an Alzheimer's therapy that targets the underlying disease processes. Lecanemab, an antibody, is for early-stage treatment and is the first drug ...

In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...

More ‘biosimilar’ medicines should be brought to market in the EU because of a regulatory policy shift on the need to carry ...

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 ...

A key result of a workshop series of European regulatory authorities and HTA agencies: Drug studies should be designed in such a way that they address both regulatory questions and the essential ...

“The benefits of Kisunla were not large enough to outweigh the risks of potentially fatal events,” the agency said, citing ...

Akebia Therapeutics gets EMA panel support for Xoanacyl to treat high phosphate & iron deficiency in CKD. Read more here.