Blog
RSS FeedPosted by Michael Wonder on 18 Apr 2023
CSL Behring receives FDA approval for Hizentra (immune globulin subcutaneous [human] 20% liquid) 50 mL pre-filled syringe
18 April 2023 - Hizentra is the first and only immune globulin available in pre-filled syringes, offering those living with ...
Posted by Michael Wonder on 18 Apr 2023
Health Canada approves Alhemo, the first subcutaneous prophylactic treatment for people living with haemophilia B with inhibitors
17 April 2023 - New treatment option for Canadians living with rare and serious X-chromosome linked congenital bleeding disorder ...
Posted by Michael Wonder on 13 Apr 2023
SAB Biotherapeutics granted fast track designation from FDA for SAB-176 influenza immunotherapy with high cross-reactivity to multiple strains of influenza
13 April 2023 - FDA greenlights advancement of SAB-176 Phase 2b trial and manufacturing approach to address influenza strain change. ...
Posted by Michael Wonder on 12 Apr 2023
Takeda receives FDA approval to expand the use of Hyqvia to treat primary immunodeficiency in children
11 April 2023 - Approval supported by pivotal Phase 3 study that demonstrated reliable infection protection in children 2-16 years pld. ...
Posted by Michael Wonder on 24 Feb 2023
FDA approves once weekly Altuviiio, a new class of factor VIII therapy for haemophilia A that offers significant bleed protection
23 February 2023 - FDA approves once weekly Altuviiio, a new class of factor VIII therapy for haemophilia A that ...
Posted by Michael Wonder on 23 Feb 2023
US FDA approves Sanofi's bleeding disorder therapy
24 February 2023 - The US FDA has approved French drug maker Sanofi's therapy to treat a type of inherited ...
Posted by Michael Wonder on 23 Feb 2023
Octapharma USA requests FDA approval for wilate VWD prophylaxis supplement
23 February 2023 - Biologics license application supplement supported by study evaluating efficacy and safety of wilate prophylaxis in adults and ...
Posted by Michael Wonder on 28 Oct 2022
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. ...
Posted by Michael Wonder on 02 Aug 2022
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, ...
Posted by Michael Wonder on 26 Jul 2022
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 ...
Posted by Michael Wonder on 15 Jul 2022
TGA approves Grifols' Xembify
15 July 2022 - Xembify is yet another presentation of human immunoglobulin. ...
Posted by Michael Wonder on 06 Jul 2022
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. ...
Posted by Michael Wonder on 01 Jun 2022
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 ...
Posted by Michael Wonder on 28 Feb 2022
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 ...
Posted by Michael Wonder on 01 Feb 2022
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 ...