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  • FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
    See more | Go to post

  • Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

    Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Authorizes Monoclonal Antibody for Treatment of COVID-19 | site |



    (November 9, 2020) - - On November 9, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima
    ...
    See more | Go to post

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  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
    04-18-2021, 04:36 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Authorizes Monoclonal Antibody for Treatment of COVID-19 | site |



    (November 9, 2020) - - On November 9, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima
    ...
    11-10-2020, 12:37 PM

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