Specialty Pharma Journal Specialty, Precision & Technology
ELSTREE, England and DURHAM, N.C., May 23, 2018 /PRNewswire/ — Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) for Coagadex® (Coagulation Factor X, Human) for prophylactic …
Tag Archives: Bio Products Laboratory
May, 2018
February, 2017
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8 February
BPL’s Gammaplex Wins FDA Approval for Treatment of PI and CITP
ELSTREE, UK AND DURHAM, NC – FEBRUARY 7, 2017 – Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Gammaplex® 10% (immune globulin intravenous [human], 10% liquid) for the treatment of primary immunodeficiency (PI) and …
October, 2015
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20 October
FDA Approves First Factor X Concentrate for Treatment of a Rare Hereditary Bleeding Disorder
The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency. In healthy individuals, the Factor X protein activates enzymes to help …