The World Health Organization prequalified Coartem Baby, the first and only antimalarial for babies, developed by Novartis in partnership with Medicines for Malaria Venture (MMV). The prequalification is intended to enable broader procurement and use in relevant global health supply chains. For drug developers and public-health stakeholders, WHO prequalification is a regulatory milestone that can accelerate access for pediatric populations and supports scaling of fixed-dose combination therapy where age-appropriate formulations are critical. The update also reinforces Novartis’ continued investment in antimalarial product development targeted to early life.