Blog
RSS FeedPosted by Michael Wonder on 07 Sep 2023
US FDA accepts marketing authorisation application for immunoglobulin Yimmugo
7 September 2023 - First marketing authorization application for a Biotest product from new "Biotest Next Level" production facility for the ...
Posted by Michael Wonder on 31 Jul 2023
US FDA accepts biologics license application for GC Biopharma's GC5107B (immune globulin intravenous (human), 10% liquid)
31 July 2023 - GC Biopharma today announced that the US FDA has accepted the Company's resubmission of the biologics ...
Posted by Michael Wonder on 26 Jul 2023
Octapharma's prothrombin complex concentrate, Balfaxar, receives FDA approval for warfarin reversal in urgent surgery & invasive procedures
26 July 2023 - Octapharma USA today announced that Balfaxar (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as ...
Posted by Michael Wonder on 17 Jul 2023
Green Cross resubmits BLA for its immunoglobulin blood product to FDA
17 July 2023 - Green Cross said it has submitted a biologics license application to the US FDA for Alyglo, ...
Posted by Michael Wonder on 15 Jun 2023
FDA accepts for review Medexus's IXinity supplemental biological license application for paediatric patients
15 June 2023 - Expanded indication would cover patients 12 years of age or younger, a population that comprises approximately ...
Posted 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 ...