Overview

• The FDA approved KEYTRUDA QLEX on September 19, a subcutaneous version of Keytruda designed to be administered in one to two minutes versus a typical 30‑minute IV infusion.
• Reports say a U.S. rollout was expected by late September, with adoption projections of 30–40% of Keytruda users within two years presented as estimates rather than company guidance.
• The FDA granted Breakthrough Therapy Designation to raludotatug deruxtecan for platinum‑resistant ovarian and related cancers, an expedited status that does not constitute approval.
• Europe’s CHMP issued a positive opinion for ENFLONSIA (clesrovimab) to prevent RSV lower respiratory tract disease in infants during their first season, with an EU decision expected by year‑end 2025.
• If authorized, ENFLONSIA would be the first weight‑independent RSV preventive option for European infants, based on data from the CLEVER and SMART trials.