Zealand Pharma Gets FDA Complete Response Letter for Hypoglycemia New Drug Application

By MarketWatch | Oct 8, 2024 at 07:21 PM EST

Zealand Pharma received a complete response letter from the FDA regarding its new drug application for dasiglucagon to treat hypoglycemia in pediatric patients with congenital hyperinsulinism. The letter is due to a pending reinspection at a manufacturing facility.

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