Blog
RSS FeedPosted by Michael Wonder on 30 Mar 2024
FDA Approves Medexus's supplemental biologics license application for Ixinity to treat haemophilia B in paediatric patients
26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Gammagard Liquid approved by US FDA for adults with chronic inflammatory demyelinating polyneuropathy
29 January 2024 - Approval supported by Phase 3 ADVANCE-CIDP open-label study data demonstrating safety and efficacy as an intravenous therapy ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Hyqvia approved by European Commission as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
30 January 2024 - At home or in office administration provides CIDP patients with a personalised treatment experience. ...
Posted by Michael Wonder on 16 Jan 2024
US FDA approves Takeda’s HyQvia as maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy
16 January 2024 - Approval based on Phase 3 ADVANCE-CIDP 1 study demonstrating a statistically significant difference in relapse rate in ...
Posted by Michael Wonder on 18 Dec 2023
GC Biopharma announces US FDA approval for Alyglo (immune globulin intravenous, human-stwk) 10% liquid for adults with primary humoral immunodeficiency
18 December 2023 - - GC Biopharma today announces that the US FDA has approved Alyglo (immune globulin intravenous, human-stwk) 10% ...
Posted by Michael Wonder on 17 Dec 2023
Takeda receives positive CHMP opinion for Hyqvia as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically ...
Posted by Michael Wonder on 09 Nov 2023
FDA approves first treatment for patients with rare inherited blood clotting disorder
9 November 2023 - Today, the US FDA approved Adzynma, the first recombinant protein product indicated for prophylactic or on demand ...
Posted by Michael Wonder on 26 Sep 2023
Takeda announces approval of Cuvitru subcutaneous immunoglobulin in Japan for patients with agammaglobulinaemia or hypogammaglobulinaemia
25 September 2023 - Approval is based on clinical studies conducted in Japan, Europe and North America confirming the ffficacy and ...
Posted by Michael Wonder on 25 Sep 2023
Once weekly Altuviiio approved in Japan as a new class of factor VIII therapy for haemophilia A
25 September 2023 - Approval demonstrates commitment to delivering innovation and a paradigm shift in the haemophilia treatment landscape. ...
Posted 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 ...