Posted by Michael Wonder on 31 Aug 2023
Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism
30 August 2023 - To ensure the most efficient regulatory process, the review by the US FDA will be conducted in two parts under the same new drug application.
Zealand Pharma today announced that the US FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in paediatric patients 7 days of age and older with congenital hyperinsulinism for up to 3 weeks of dosing.
