Biopharmaceutical company Xeris Biopharma Holdings (Nasdaq: XERS) announced on Monday that the US Food and Drug Administration (FDA) has approved its supplemental new drug application for Gvoke VialDx.
The glucagon formulation is now authorised for use as a diagnostic aid during radiologic examinations to temporarily inhibit gastrointestinal movement in adult patients.
Xeris has partnered with American Regent to commercialise Gvoke VialDx in the United States. Under the agreement Xeris will supply the product, while American Regent will handle commercialisation. Financial terms were not disclosed.
Gvoke VialDx is the first concentrated, ready-to-dilute liquid glucagon available for the procedural gastroenterology market. It will be offered in 1-count and 10-count packages of 1 mg per 0.2 mL single-dose vials.
Availability is expected in the third quarter of 2025.
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