Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Northfield Laboratories, a developer of hemoglobin-based oxygen-carrying red blood cell substitute, has submitted a biologics license application to the FDA for PolyHeme, the company's human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available.
Subscribe to our email newsletter
The company has also requested priority review, based on the potential for PolyHeme to address a critical, unmet medical need.
By regulation, the FDA has 60 calendar days to review the biologics license application (BLA) for completeness and to make a determination regarding priority review of the application.
Steven Gould, chairman and CEO of Northfield Laboratories, said: “This submission is the culmination of the development of PolyHeme for its initial clinical indication. We firmly believe in PolyHeme’s potential to save the lives of patients for whom blood transfusion is not an option.”