After several failed attempts at US regulatory approval, Dynavax Technologies Corp.'s hepatitis B vaccine Heplisav-B will finally enter the market in early 2018 with a relatively clean label but a postmarketing study that is 25% larger than originally proposed.
Dynavax's Hep B Vaccine Finally Clears US FDA With Clean Label But Larger Safety Study
Heplisav-B labeling notes myocardial infarction imbalance in one trial but also apparent absence of a causal relationship; sponsor will conduct a postmarketing safety cohort study involving 50,000 subjects, 10,000 more than initially planned.
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