FDA approves Spriaso’s NDA for codeine antitussive with anti-histamine
Jointly developed with Nexgen Pharma, Tuxarin ER will be the first product to provide long lasting cough suppression with a safer opiate that is less prone to respiratory
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.