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 ...

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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 ...

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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% ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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