FDA approves prior approval supplement for Bivigam

10 May 2019 - ADMA Biologics announces that the U.S. FDA has approved the Company’s prior approval supplement for Bivigam (immune ...

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PHARMAC fully funding innovative improvements in haemophilia treatment

30 April 2019 - PHARMAC has today provided haemophilia patients fully funded access to new innovative treatment options which will ...

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FDA approves Asceniv, a novel intravenous immune globulin

1 April 2019 - Approved for use in the treatment of primary humoral immunodeficiency disease in adults and adolescents (12 to ...

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Decision to make changes to funded haemophilia treatments

8 March 2019 - PHARMAC is pleased to announce changes to funded haemophilia treatments that will result in two new ...

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Novo Nordisk receives US FDA approval of Esperoct (turoctocog alfa pegol, N8-GP)

19 February 2019 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Esperoct ...

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Proposal for changes to funded haemophilia treatments

29 January 2019 - PHARMAC is proposing to make changes to the funding of haemophilia treatments from 1 May 2019, ...

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ADMA Biologics submits response and provides supplemental information to FDA for Bivigam complete response letter

7 January 2019 - ADMA Biologics announces that the Company has submitted responses to the U.S. FDA complete response letter received ...

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ADMA Biologics provides regulatory update on Bivigam PAS submissions

19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product. ...

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FDA promotes the development and adoption of innovations that can ensure the continued safety of the U.S. blood supply

4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments ...

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Data from patient registries to replace clinical trials in previously untreated haemophilia patients

30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...

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Bayer receives EU approval for its haemophilia A treatment Jivi

27 November 2018 - The safety and efficacy profile of Jivi has been demonstrated in more than five years of clinical ...

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Octapharma receives Swissmedic approval for fibryga to treat congenital and acquired fibrinogen deficiencies

26 November 2018 - Octapharma today announced that the Swiss Agency for Therapeutic Products, Swissmedic, granted marketing authorisation to its new ...

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Health Canada has now authorised Adynovate [anti-haemophilic factor (recombinant), PEGylated] in paediatrics for treatment of children under 12 with haemophilia A

26 November 2018 - Canadian children now have access to Adynovate, which offers a twice-weekly prophylaxis dosing schedule and on-demand control ...

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ICER issues final report on long-term prophylaxis for hereditary angioedema, provides policy recommendations to improve cost-effectiveness

15 November 2018 - Cost-effectiveness and coverage considerations hinge on the frequency and intensity of attacks. ...

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Bayer receives approval for haemophilia A treatment Jivi

24 October 2018 - Extended half-life product that offers a reduction in dosing frequency and improved bleeding protection. ...

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