Dynavax caps a long-running regulatory saga with an FDA OK for hep B vaccine Heplisav
Regulators have been fretting for the last 5 years about Dynavax’s Heplisav, a hepatitis B vaccine linked to a long-running string of unexplained safety issues, including an imbalance in the rate of cardio events that suggested an underlying issue no one could clearly define. But Thursday night came formal word that Dynavax’s long regulatory odyssey in search of an approval — after two earlier rejections — was over. The FDA sanctioned the vaccine for a commercial launch.
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