European Commission
FDA Approves Abeona's Zevaskyn, EC Authorizes Krystal's Vyjuvek for Rare Skin Disease
Both gene therapies were approved as treatments for dystrophic epidermolysis bullosa, a rare and debilitating genetic skin condition.
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.
EC Approves Vertex's Kaftrio, Kalydeco Cystic Fibrosis Drug Combo for More Patients
The new approval makes the regimen an option for around 4,000 patients in the EU who have at least one non-class I CFTR mutation.
BMS's Breyanzi Gains European Approval as Third-Line Treatment for Follicular Lymphoma
The EC approved the CAR T-cell therapy based on data from a Phase II study showing a 94 percent complete response rate.
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.