Swiss medicines regulator Swissmedic has approved Novartis AG’s Coartem Baby, the world’s first antimalarial formulated specifically for newborns and very small infants weighing between 2 kg and 5 kg. The dissolvable, cherry-flavoured tablets can be mixed with breast milk, addressing dosing and adherence challenges that arise when older-child formulations are split for babies. The decision, announced on 8 July, follows a fast-track review carried out with the World Health Organization. Eight African nations that participated in clinical assessments—Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda—are expected to grant their own approvals within about 90 days, paving the way for distribution across malaria-endemic regions within weeks. Novartis says it will supply the medicine largely on a not-for-profit basis. Regulators and public-health groups view the product as closing a critical treatment gap for the youngest malaria patients, who until now have been treated with scaled-down doses intended for older children, increasing overdose risks. Malaria caused an estimated 263 million infections and 597,000 deaths in 2023, with children under five accounting for three-quarters of fatalities, according to the WHO.