The European Medicines Agency’s CHMP recommended four new medicines in March and issued a label outcome for multiple indications. CHMP backed extended options for extended-stage small cell lung cancer therapies, while also rebuffing an expanded-label request for Vanda’s Hetlioz in Smith-Magenis syndrome. The committee also supported a new subcutaneous form of Sanofi’s multiple myeloma therapy, marking continued efforts to expand administration flexibility across hematology regimens. Together, the March CHMP opinions show regulators balancing route-of-administration updates with evidence thresholds for pediatric and rare disease label expansion. For companies, the decisions determine the next steps toward marketing authorization and revisions in EU prescribing, including dosing logistics that can materially affect uptake and real-world implementation.