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Hep-B vaccine four-year battle for FDA approval is finally won

05:52 EST 10 Nov 2017 | Pharmafile

Dynavax had said it was the last throw of the dice for its hepatitis B vaccine, Hepislav-B – the data pointed to it entering the market as best-in-class but it had received one knock-back after another, culminating in a final three month user fee action data delay.

It was first rejected in 2013 and then later in 2016, both times requiring more data on safety and post-marketing plans. In the end, the FDA agreed that the data supported an approval and it proved that persistence does pay off for Dynavax.

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IMAGE: Dynavax

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Original Article: Hep-B vaccine four-year battle for FDA approval is finally won

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