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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FDA approves Octapharma’s Octagam 10% for adult dermatomyositis

20 July 2021 - FDA approval based on positive results of international, multi-center ProDERM study. ...

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Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in factor VII deficiency

28 June 2021 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for Marzeptacog alfa (activated), MarzAA, ...

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FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder

4 June 2021 - Today, the U.S. FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type ...

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Campaign launched for life-sustaining treatment access across Canada

31 May 2021 - Alpha-1 Canada publicly launched Access for Alphas today, a campaign aimed at raising the awareness of alfa-1 ...

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TGA approves Octapharma's Cutaquig

12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ. ...

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US FDA accepts GC Pharma’s biologics license application for immunoglobulin 'GC5107'

5 May 2021 - A significant milestone towards entering the world's largest plasma product marketplace. ...

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FDA begins review of GC Pharma’s blood product for marketing authorisation

27 April 2021 - The U.S. FDA has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for ...

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