China is not as big a player in the manufacturing of key ingredients used to make brand and generic medicines as previously ...

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

CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.

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

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

The European Commission on Tuesday authorized the use of Eisai and Biogen's drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than ...

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 ...

Substandard and fake medicines remain a major threat in Africa, risking lives and fuelling drug resistance. A unified ...

The commission approved the new formulation in first- and second-line NSCLC settings, in which intravenous Rybrevant is already available.

This article examines post-market drug safety, highlighting surveillance mechanisms, regulatory responses, and case studies ...

Halozyme Therapeutics (HALO) announced that Bristol Myers Squibb (BMY) received a positive opinion from the Committee for Medicinal Products ...