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Tag: dynavax

  • Dynavax says FDA rejects its hepatitis B vaccine

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    (Reuters) – The U.S. Food and Drug Administration rejected Dynavax Technologies Corp's marketing application for its hepatitis B vaccine, Heplisav-B, for the second time in three years, sending the company's shares tumbling 71 percent in premarket trade. The drug developer said on Monday it received a “complete response letter” from the FDA, seeking information about…

  • Dynavax says FDA rejects its hepatitis B vaccine

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    creative
    in

    (Reuters) – The U.S. Food and Drug Administration rejected Dynavax Technologies Corp's marketing application for its hepatitis B vaccine, Heplisav-B, for the second time in three years, sending the company's shares tumbling 71 percent in premarket trade. The drug developer said on Monday it received a “complete response letter” from the FDA, seeking information about…

  • Dynavax to resubmit hep B vaccine for approval after positive data

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    Dynavax Technologies Corp said its experimental hepatitis B vaccine was found to be safe and effective in a late-stage study, paving the way for the company to resubmit its marketing application. The earlier marketing application for the vaccine, HEPLISAV-B, was rejected in February 2013 by the U.S. Food and Drug Administration (FDA), which sought additional…

  • Dynavax to resubmit hep B vaccine for approval after positive data

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    by

    publisher
    in

    Dynavax Technologies Corp said its experimental hepatitis B vaccine was found to be safe and effective in a late-stage study, paving the way for the company to resubmit its marketing application. The earlier marketing application for the vaccine, HEPLISAV-B, was rejected in February 2013 by the U.S. Food and Drug Administration (FDA), which sought additional…

  • The Best Diet Ever: Three Key Ingredients

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    As weight loss and maintenance is one of my specialties, I am often asked, “What is the best diet?” People are often disappointed by my response. I tell them, “The best diet meets three conditions:It's a healthy diet.It's a diet that includes your favorite foods, in moderation, even if they're not entirely healthy.It's a diet…

  • The Best Diet Ever: Three Key Ingredients

    —

    by

    publisher
    in

    As weight loss and maintenance is one of my specialties, I am often asked, “What is the best diet?” People are often disappointed by my response. I tell them, “The best diet meets three conditions:It's a healthy diet.It's a diet that includes your favorite foods, in moderation, even if they're not entirely healthy.It's a diet…