Blog
RSS FeedPosted by Michael Wonder on 31 May 2023
TGA approves pathway for more plasma donors
30 May 2023 - The Government welcomes the Therapeutic Goods Administration’s approval of a ‘plasma pathway’, allowing a larger pool of ...
Posted by Michael Wonder on 30 May 2023
Inhibrx granted fast track designation for INBRX-101 for the treatment of alfa-1 antitrypsin deficiency
30 May 2023 - Inhibrx announced today that the US FDA granted fast track designation to INBRX-101, an optimised recombinant ...
Posted by Michael Wonder on 20 May 2023
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
19 May 2023 - Sobi today announced that the EMA has accepted and validated a marketing authorisation application for efanesoctocog alfa, ...
Posted 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 28 Sep 2022
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 ...
Posted by Michael Wonder on 08 Sep 2022
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 ...
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 ...