Regulatory round-up: 26 May 2026

26 May 2026

The past week was led by a busy European Medicines Agency review cycle, with its human medicines committee backing eight new medicines and 18 indication extensions, including an oral tablet formulation for Wegovy. The US Food and Drug Administration also added a fresh oncology approval for Datroway in triple-negative breast cancer.

Australia and Brazil supplied several product-level updates. The Therapeutic Goods Administration published an AusPAR for Adzynma, while Brazil’s Agência Nacional de Vigilância Sanitária approved Nurtec ODT for migraine, Vyalev for advanced Parkinson’s disease and a first generic dapagliflozin/metformin combination.

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