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 ...

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 ...

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the ...

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 ...

Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy ...

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

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 ...

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

The European Medicines Agency (EMA) has recommended refusal of a marketing authorization for donanemab, which targets the treatment of early Alzheimer’s disease (AD). The agency's Committee for ...

SHANGHAI, China & JERSEY CITY, N.J., March 28, 2025--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA ...

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 ...