EMA
European Commission Approves J&J's Subcutaneous Rybrevant for Certain NSCLC Patients
The commission approved the new formulation in first- and second-line NSCLC settings, in which intravenous Rybrevant is already available.
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.
In Brief This Week: Eisai, Biogen, Carsgen, VolitionRx, Ocugen, Regenxbio, Guardant Health, Avacta
News items for the week of March 3, 2025.
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.