CSL Behring has announced that Kcentra (prothrombin complex concentrate [human]) has received the US Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of acquired coagulation factor deficiency induced ...
Tags: CSL Behring, Medicine
US-based CSL Behring has announced the availability of DNA1 Advanced Alpha-1 Screening (DNA1), a new test kit designed to improve diagnosis of Alpha-1 antitrypsin deficiency (Alpha-1). Alpha-1 is a serious hereditary condition that is ...
Tags: Diagnosing Kit, CSL Behring
CSL Behring has received approval from the US Food and Drug Administration (FDA) for a new 10g (50mL) vial size of Hizentra, an immune globulin subcutaneous (human) liquid drug. Hizentra, which is claimed to the first and only 20% ...
Tags: CSL Behring, Hizentra
CSL Behring has obtained expanded label approval for a C1-esterase inhibitor (C1-INH) concentrate, Berinert, for short-term prophylaxis in adults and children with hereditary angioedema (HAE) in 23 European countries. Berinert is ...
CSL Behring's Privigen has obtained marketing authorization from the European Commission for use in chronic inflammatory demyelinating polyneuropathy (CIDP). Privigen is an immune globulin intravenous [human], 10% liquid, developed for ...
Tags: CSL Behring Privigen, European Marketing Authorization
CSL Behring has received FDA orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The designation was granted for the treatment and prophylaxis of bleeding episodes in ...
Tags: CSL Behring, rIX-FP, hemophilia B
CSL Behring has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen (immune globulin intravenous [human], 10% liquid for intravenous administration) in Chronic Inflammatory Demyelinating ...
Tags: CSL Behring, Variation Application, Privigen, CIDP