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 ...

Leqembi gains European approval after CHMP reversal, despite safety concerns tied to brain swelling and bleeding in Alzheimer ...

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 ...

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 ...

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 ...

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 ...