The European Medicines Agency’s CHMP recommended approval of four new medicines in March and also supported two existing FDA-approved therapies for extended-stage small cell lung cancer, while rejecting an expanded label for Vanda’s Hetlioz in Smith-Magenis syndrome. The package reflects CHMP’s continued scrutiny of evidence strength for label expansions alongside positive opinions for new therapies. A standout element is CHMP’s differentiation among indications within the same medicinal products—advancing oncology therapies where committee consensus is stronger while curbing additional claims for a neurodevelopmental indication where expanded evidence did not meet the committee threshold. The decision set is a key checkpoint for companies planning EU launches, pricing negotiations, and subsequent national reimbursement dossiers.