The World Health Organization has prequalified Coartem Baby, Novartis’ pediatric antimalarial combination developed with Medicines for Malaria Venture. The designation makes the product eligible for WHO procurement channels for infants, addressing supply and access constraints that have limited pediatric coverage in many malaria-endemic markets. Coartem Baby is positioned as the first and only antimalarial for babies within the prequalification decision described in the report. The move adds a regulatory milestone in the life cycle of a product designed specifically for the youngest age group. For developers and public-health counterparties, WHO prequalification remains a key lever for scaling impact in global markets, particularly for pediatric dosing formulations that require dedicated development and monitoring.