• FDA authorizes AstraZeneca antibody cocktail for pre-exposure prevention of COVID-19

    1 month ago - By Healio

    The FDA has for the first time approved an emergency use authorization for a long-acting monoclonal antibody cocktail designed to prevent symptomatic COVID-19 among adults and children aged 12 years and older.
    According to data submitted to the FDA, AstraZeneca's Evusheld , also known as AZD7442, can reduce the risk for developing symptomatic COVID-19 by 77%, compared with placebo, among unvaccinated adults without prior SARS-CoV-2 infection at increased risk for inadequate immunization response.
    Alfred H.J. Kim, MD, PhD, assistant professor of medicine in the
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  • FDA approves gel for bacterial vaginosis

    FDA approves gel for bacterial vaginosis

    1 month ago - By Healio

    Daré Bioscience announced the FDA approval of Xaciato, a vaginal gel, for the treatment of bacterial vaginosis in females aged 12 years or older.
    Xaciato was formerly known as DARE-BVI.
    According to Daré, bacterial vaginosis is the most common cause of vaginitis globally and is estimated to affect approximately 21 million women in the United States. The prevalence is higher among Black and Hispanic women compared with white women .
    “The FDA approval of Xaciato marks a major milestone, not only for Daré as a
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