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November 12, 2026

FDA and EMA waive paediatric studies for Shanton’s gout candidate

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted paediatric clinical trial waivers to Shanton Pharma for its lead candidate SAP-001, easing the drug’s regulatory paths to approval.

FDA and EMA waive paediatric studies for Shanton’s gout candidate