Regulatory round-up: 29 July 2026

Medicines regulators across major markets issued a mix of approvals, class-wide safety warnings, a product defect notification and consultation activity over the past week, spanning central nervous system, metabolic, ophthalmology and vaccine areas.

The latest round-up features a first-in-class attention-deficit hyperactivity disorder approval from the US Food and Drug Administration (FDA), a dozen positive opinions from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), a class-wide vision-risk warning and a labeling consultation from the Therapeutic Goods Administration (TGA) in Australia, and a product defect notification from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The table below summarizes official human medicines regulatory updates from the past seven days.