Blog
RSS FeedPosted by Michael Wonder on 13 Jul 2019
Esperoct is now approved in Canada for the treatment of haemophilia A in both children and adults
12 July 2019 - New treatment can help Canadians living with haemophilia A better manage their bleeding episodes ...
Posted by Michael Wonder on 08 Jul 2019
ADMA Biologics receives FDA approval for license transfers for Bivigam and Nabi-HB
8 July 2019 - All aspects of the Biotest Therapy Business Unit acquisition are successfully completed. ...
Posted by Michael Wonder on 04 Jul 2019
Grifols announces FDA approval of Xembify, 20% subcutaneous immunoglobulin for primary immunodeficiencies
4 July 2019 - Xembify is Grifols’ first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies. ...
Posted by Michael Wonder on 21 Jun 2019
Esperoct (turoctocog alfa pegol, N8-GP) approved in the EU
20 June 2019 - Novo Nordisk today announced that the European Commission has granted marketing authorisation for Esperoct for the treatment ...
Posted by Michael Wonder on 12 May 2019
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 ...
Posted by Michael Wonder on 03 Apr 2019
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 ...
Posted by Michael Wonder on 20 Feb 2019
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 ...
Posted by Michael Wonder on 07 Jan 2019
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 ...
Posted by Michael Wonder on 20 Dec 2018
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. ...
Posted by Michael Wonder on 04 Dec 2018
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4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments ...
Posted by Michael Wonder on 30 Nov 2018
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 ...
Posted by Michael Wonder on 28 Nov 2018
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 ...
Posted by Michael Wonder on 28 Nov 2018
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 ...
Posted by Michael Wonder on 28 Nov 2018
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 ...
Posted by Michael Wonder on 26 Oct 2018
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. ...