29 January 2024 - Approval supported by Phase 3 ADVANCE-CIDP open-label study data demonstrating safety and efficacy as an intravenous therapy ...
16 January 2024 - Approval based on Phase 3 ADVANCE-CIDP 1 study demonstrating a statistically significant difference in relapse rate in ...
18 December 2023 - - GC Biopharma today announces that the US FDA has approved Alyglo (immune globulin intravenous, human-stwk) 10% ...
9 November 2023 - Today, the US FDA approved Adzynma, the first recombinant protein product indicated for prophylactic or on demand ...
7 September 2023 - First marketing authorization application for a Biotest product from new "Biotest Next Level" production facility for the ...
31 July 2023 - GC Biopharma today announced that the US FDA has accepted the Company's resubmission of the biologics ...
26 July 2023 - Octapharma USA today announced that Balfaxar (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as ...
17 July 2023 - Green Cross said it has submitted a biologics license application to the US FDA for Alyglo, ...
15 June 2023 - Expanded indication would cover patients 12 years of age or younger, a population that comprises approximately ...
30 May 2023 - Inhibrx announced today that the US FDA granted fast track designation to INBRX-101, an optimised recombinant ...
18 April 2023 - Hizentra is the first and only immune globulin available in pre-filled syringes, offering those living with ...
13 April 2023 - FDA greenlights advancement of SAB-176 Phase 2b trial and manufacturing approach to address influenza strain change. ...
11 April 2023 - Approval supported by pivotal Phase 3 study that demonstrated reliable infection protection in children 2-16 years pld. ...
23 February 2023 - FDA approves once weekly Altuviiio, a new class of factor VIII therapy for haemophilia A that ...
24 February 2023 - The US FDA has approved French drug maker Sanofi's therapy to treat a type of inherited ...