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Keyword: monoclonaltherapy

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  • FDA announces Evusheld is not currently authorized for emergency use in the U.S.

    01/26/2023 9:43:44 PM PST · by blueplum · 1 replies
    FDA ^ | 26 Jan 2023 | FDA PSA
    Update [1/26/2023] The U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency. Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants. According to the most recent CDC Nowcast data, these variants are projected to be responsible for more than 90% of current infections in the U.S. This...
  • ‘I felt this huge relief’: how antibody injections could free the immunosuppressed under Covid

    09/20/2021 12:11:34 AM PDT · by blueplum · 19 replies
    The Guardian UK ^ | 19 September 2021 | Benjamin Ryan
    FDA expected to issue full emergency authorization for periodic antibody injections, or PrEP, to complement vaccinations A proud sports mom, Shantay Brown longs to pack into a crowded stadium for her son’s Ohio State football games and scream her face off over the action on the field. But as with so many other simple pleasures in the age of Covid-19, nothing is that simple for Brown. The 47-year-old Missouri resident takes immunosuppressant medication for lupus. Consequently, her body has mounted virtually no antibody response to the coronavirus vaccine – leaving her in persistent peril.... ...In August, the FDA granted further...