Northfield submits US BLA for PolyHeme
The USA's Northfield Laboratories has submitted a Biologics License Application to the Food and Drug Administration for PolyHeme, its human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when transfusions are not available.
The firm has requested Priority Review for the application and the FDA has 60 calendar days to review the BLA for completeness and to make a determination.
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