Congenital MeSH qualifier
FDA Delays Approval of Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Due to Third-Party Manufacturing Issues
Zealand Pharma, dasiglucagon, congenital hyperinsulinism, FDA, Complete Response Letter, third-party manufacturing issues
Zealand’s Hypoglycemia Drug Faces Second FDA Rejection Due to Manufacturing Issues
Zealand Pharma, FDA rejection, dasiglucagon, congenital hyperinsulinism, hypoglycemia, CDMO inspection