European Medicines Agency
CHMP Issues Positive Recommendation for Jazz Pharmaceuticals' Ziihera
If the European Commission approves this treatment, it'll be the first HER2-targeted agent for HER2-positive biliary tract cancer available to patients in the EU.
European Commission Approves Biogen, Eisai's Leqembi in Early Alzheimer's Disease
CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.
EMA's CHMP Recommends Against Approval of Eli Lilly's Alzheimer's Drug Kisunla in Europe
The committee determined the clinical benefits of the drug don't outweigh the potentially fatal risk of ARIA.
EC Resumes Review of Eisai, Biogen's Leqembi Application After CHMP Reaffirms Positive Opinion
The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.
AstraZeneca, Daiichi Sankyo Withdraw EU Application for Dato-DXd in Nonsquamous NSCLC
The decision follows a similar one in the US and is due to the drug's failure to significantly improve overall survival versus chemo in the TROPION-Lung01 trial.