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

Pharma Tech

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

Nov 12, 2026, 10:14 AM

Read Full Article → FDA and EMA waive paediatric studies for Shanton’s gout candidate

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

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SAP-001 will not require paediatric studies in market authorisation applications for hyperuricemia and gout.