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

Leqembi approved by the EU for early-stage Alzheimer’s in patients with specific ApoE4 gene profile, marking a milestone in ...

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

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 ...

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 ...

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

The antibody lecanemab is the first authorized therapy in Europe that targets the underlying process of Alzheimer's, rather than only treating symptoms.

The European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line ...

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 Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it recommended refusing marketing authorization for it. The agency’s Committee ...

The European Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it recommended refusing marketing authorization for it. The agency’s Committee for ...