The EMA’s CHMP recommended four new medicines in March, including opinions covering oncology therapies and label updates. CHMP also recommended two FDA-approved therapies for extended-stage small cell lung cancer while rebuffing an expanded label for Vanda’s Hetlioz (treating Smith-Magenis syndrome). The set of recommendations highlights how European review bodies continue to use incremental label logic—adding indications where evidence supports clinical benefit and narrowing where the CHMP concludes the current data do not meet requirements. For companies with cross-market development plans, CHMP positions also provide a clearer timeline for commercialization strategy across the EU and reinforce how companies should anticipate follow-on evidence requests.