9 October 2024 - The re-inspection of the facility was completed in August/September 2024 for which a new inspection classification is pending.
Zealand Pharma today announced that the US FDA has issued a complete response letter for Part 1 of the new drug application for dasiglucagon for the prevention and treatment of hypoglycaemia in paediatric patients 7 days of age and older with congenital hyperinsulinism for up to 3 weeks of dosing.
Read Zealand Pharma press release