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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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. ...

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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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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 ...

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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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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 ...

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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. ...

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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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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 ...

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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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