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Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration 2022-12-22

Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration     CT-P13 SC is a novel subcutaneous formulation of infliximab The Biologics License Application (BLA) submission is based on phase I...

게시물 검색
  • 75
    Celltrion Healthcare Presents Positive One-Year Da..
    Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab, YuflymaTM(CT-P17) in Patients With Rheumatoid Arthritis at EULAR 2021 One-year data have shown equivalent …
    2021-06-02
  • 74
    Celltrion Confirms Neutralising Potency Against Em..
    Celltrion Confirms Neutralising Potency Against Emerging SARS-CoV-2 Variants With Anti-COVID-19 Monoclonal Antibody Treatment regdanvimab (CT-P59) CT-P59 demonstrated neutralising capability against key emerging mutations, including SARS-CoV-2 …
    2021-05-18
  • 73
    Celltrion’s anti-COVID 19 monoclonal antibody trea..
    Celltrion’s anti-COVID 19 monoclonal antibody treatment, regdanvimab (CT-P59), demonstrates neutralising effect against the South African variant (B.1.351) Pre-clinical data for Celltrion’s monoclonal antibody treatment regdanvimab (CT-P59) sho…
    2021-04-29
  • 72
    Celltrion Healthcare receives positive CHMP opinio..
    Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima®SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis The Committee for Medicinal Products for …
    2021-03-31
  • 71
    EMA issues advice on the use of Celltrion’s anti-C..
    EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Union Positive scientific opinion adopted by the Committee for Medicinal Products for Hum…
    2021-03-26
  • 70
    Celltrion Healthcare receives European Commission ..
    Yuflyma™ (CT-P17) is the first adalimumab biosimilar with a high concentration, low-volume and citrate-free formulation; 60% of adalimumab market captured by high concentration formulation in Europe according to IQVIA Yuflyma™ is approved in all…
    2021-02-15
  • 69
    Celltrion Develops Tailored Neutralising Antibody ..
    Celltrion is on track developing a neutralising antibody cocktail with Regdanvimab (CT-P59) tailored to fight against the emerging new variants CT-P59 demonstrated neutralising capability against key emerging mutations, including the UK variant …
    2021-02-11
  • 68
    Celltrion’s COVID-19 treatment candidate receives ..
    Celltrion’s COVID-19 Treatment Candidate Receives Korean MFDS Conditional Marketing Authorisation Regdanvimab (CT-P59) receives conditional marketing authorisation from the Korean Ministry of Food and Drug Safety (MFDS); first anti-COVI…
    2021-02-05
  • 67
    Celltrion Group announces positive top-line effica..
    Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59 CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% …
    2021-01-13
  • 66
    Celltrion submits application for Conditional Mark..
    Celltrion Submits Application for Conditional Marketing Authorisation of Its COVID-19 Treatment Candidate CT-P59 to the Korean MFDS Celltrion submitted today an application for Conditional Marketing Authorisation of CT-P59, an anti-COVI…
    2020-12-29