News Release Archive

This section features CSL Behring news releases that are more than 18 months old. Click the tabs to select releases in your area of interest. Click Resources to find additional background material on CSL Behring.

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Bleeding Disorders
Hereditary Angioedema (HAE)
Fluid Management

Bleeding Disorders

14 December 2016 Health Canada Approves CSL Behring’s AFSTYLA for the Treatment of Hemophilia A

Health Canada has approved AFSTYLA [Antihemophilic Factor VIII (Recombinant), SingleChain], CSL Behring’s novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A.

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14 November 2016 AFSTYLA®, for Haemophilia A, Receives Positive Opinion from European Medicines Agency CHMP

Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AFSTYLA® [Recombinant Human Coagulation Factor VIII, Single Chain] for patients with haemophilia A.

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03 October 2016 Therapeutic Goods Administration Approves IDELVION® - CSL Behring’s Novel Recombinant Haemophilia B Treatment with up to 14-day Dosing Intervals

CSL Behring announced that the Australian Therapeutic Goods Administration (TGA) has approved IDELVION®[albutrepenonacog alfa] in patients with haemophilia B (congenital factor IX deficiency).

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29 September 2016 Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves CSL Behring’s IDELVION® -- The First and Only Hemophilia B Therapy with Up to 14-day Dosing Intervals

Global biotherapeutics leader CSL Behring announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IDELVION® [Albutrepenonacog Alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the prevention of bleeding tendency in patients with factor IX deficiency.

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27 July 2016 CSL Behring Presents Pivotal Efficacy Data for AFSTYLA® In Adolescents and Children with Hemophilia A at the World Federation of Hemophilia 2016 World Congress

CSL Behring today presented data from a Phase III pivotal study of AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain] in hemophilia A patients less than 12 years of age at the XXXII International Congress of the World Federation of Hemophilia (WFH) in Orlando, Fla.

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