The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) backed four new medicines in March, including a new subcutaneous formulation of Sanofi’s Sarclisa in multiple myeloma. CHMP also recommended two FDA-approved therapies for extended-stage small cell lung cancer, while rejecting an expanded label for Vanda’s Hetlioz in Smith-Magenis syndrome. The CHMP opinions signal where regulators are converging for oncology and rare disease populations, with guidance moving patients closer to potential approvals and payers preparing for new treatment pathways. The outcomes also reflect ongoing scrutiny of label expansion claims in neurodevelopmental indications. The decision set provides a near-term view of what could reach EU patients following subsequent EMA steps, with CHMP recommendations shaping both commercial timelines and clinical adoption plans.