Health Canada approves Rebinyn (coagulation factor IX (recombinant), pegylated) for the treatment of routine prophylaxis to prevent or reduce frequency of bleeding episodes in children with haemophilia B

27 October 2022 - Expanded indication for Rebinyn will continue to support Canadian paediatric patients living with haemophilia B. ...

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CSL receives manufacturing and marketing authorisation in Japan for “Berinert SC injection 2000,” as a medicine for prevention of acute hereditary angioedema attacks

26 September 2022 - At home subcutaneous therapy advances treatment options for patients and marks a milestone in 40 years of ...

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Grifols enters into agreement with Canadian Blood Services to accelerate self-sufficiency in immunoglobulins for Canada

7 September 2022 - The country, with an increasing immunoglobulin usage rate, currently imports about 85% of its immunoglobulin demand for ...

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Novo Nordisk receives FDA approval for Rebinyn for routine prophylaxis to prevent bleeding in people living with haemophilia B

29 July 2022 - Novo Nordisk announced today that the US FDA has approved the supplemental biologics license application for Rebinyn, ...

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LFB announces the approval of Cevenfacta (eptacog beta) in the European Union

25 July 2022 - The first new bypassing agent approved in the European Union for the treatment and control of bleeding ...

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TGA approves Grifols' Xembify

15 July 2022 -  Xembify is yet another presentation of human immunoglobulin. ...

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Health Canada approves HyQvia, a new treatment for Canadians with immune deficiencies

 6 July 2022 - New immunoglobulin treatment offers Canadian patients option of subcutaneous once-monthly (every three or four weeks) dosing. ...

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FDA grants efanesoctocog alfa breakthrough therapy designation for haemophilia A

1 June 2022 - Designation is based on XTEND-1 Phase 3 study data demonstrating a clinically meaningful prevention of bleeds and ...

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Novo Nordisk expands product offerings in Canada for the treatment of haemophilia A in both children and adults, with availability of Esperoct and Zonovate

1 April 2022 - Newly available treatments can help Canadians living with haemophilia A better manage their bleeding episodes ...

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GC Pharma receives complete response letter from the U.S. FDA for Alyglo

27 February 2022 - GC Pharma today announced that it has received a complete response letter from the U.S. FDA in ...

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FDA approves prophylactic treatment with Vonvendi [von Willebrand factor (recombinant)] for adult patients living with severe type 3 von Willebrand disease

31 January 2022 - Vonvendi [von Willebrand factor (recombinant)] is the first and only treatment approved for routine prophylaxis to reduce ...

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FDA approves Octapharma’s Cutaquig 16.5% for paediatric PI patients, providing flexible treatment options

7 December 2021 - Families, providers can utilise flexible infusion schedule to meet patient needs. ...

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FDA orphan drug approval: Octapharma’s Octagam 10% receives 7 years of market exclusivity for adult dermatomyositis

30 August 2021 - Octagam 10% expected to become the first treatment option for adults with rare immune-mediated inflammatory disease. ...

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GC Pharma announces GreenGene F approval in China for the treatment of haemophilia A

12 August 2021 - GreenGene F now approved in China, provides more haemophilia A patients access to proven therapy. ...

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FDA approves new Berinert (C1 esterase inhibitor, human (intravenous)) administration kit for increased patient convenience

3 August 2021 -  CSL Behring has received U.S. FDA approval for its supplemental request for co-packaging of a convenience ...

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