CHMP
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.
CHMP Recommends Approval of Krystal Biotech's Gene Therapy Vyjuvek for Wound Skin Condition
Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.
CHMP Recommends Vertex's Kaftrio, Kalydeco Combo for Additional Cystic Fibrosis Patients
The committee supports approving the CFTR modulator for patients 2 years and older with at least one non-class I CFTR gene mutation.