The World Health Organization has prequalified Coartem Baby, Novartis’ antimalarial combination for infants, in a milestone that expands WHO-recognized treatment options for younger children. The product is being developed by Novartis in partnership with Medicines for Malaria Venture. WHO prequalification can unlock broader procurement and use in national programs that rely on its standards. For manufacturers, it also serves as a regulatory signal that quality, efficacy, and performance requirements have been met for routine rollout.