Active ingredient: Antihemophilic Factor (recombinant): nominally 250 IU, 500 IU, 1,000 IU, or 2,000 IU per vial; powder for IV infusion after reconstitution; plasma/ albumin-free; preservative-free; ...

− Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative ...

The development of neutralizing anti–factor VIII alloantibodies (inhibitors) in patients with severe hemophilia A may depend on the concentrate used for replacement therapy. Of 303 patients screened, ...

Am J Health Syst Pharm. 2006;63(17):1641-1646. Our institution, the University of Virginia Health System (UVHS), added factor VIIa (recombinant) to its formulary on August 27, 1999. Informal ...

U.S. FDA Grants Approval for Jivi® Antihemophilic Factor (Recombinant), PEGylated-aucl in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A (Congenital Factor VIII Deficiency) Not ...

Factor VIII replacement products have improved the care of patients with hemophilia A, but the short half-life of these products affects the patients’ quality of life. The half-life of recombinant ...

DEERFIELD, Ill.--Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved OBIZUR [Antihemophilic Factor (Recombinant), Porcine ...

Hemophilia A is characterized by FVIII deficiency, leading to joint bleeds and chronic pain despite prophylactic therapy. Treatment options vary in sustaining FVIII levels, with gene therapy and ...

WALTHAM, Mass.--(BUSINESS WIRE)--Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, today presented initial clinical data for BIVV001 ...

Hemophilia is characterized by genetic mutations resulting in the deficiency of factors critical to the normal process of coagulation, sometimes resulting in spontaneous bleeding into soft tissue, ...

Endotoxin testing is critical for quality control in drug production, as it has a direct impact on pharmaceutical safety and effectiveness. Traditionally Limulus Amebocyte Lysate (LAL) testing is used ...

Not intended for media outside the U.S. WHIPPANY, N.J., May 19, 2025--(BUSINESS WIRE)--Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi ®, a recombinant DNA-derived, ...