Dynavax Technologies Corp. looks poised to finally get its hepatitis B vaccine Heplisav (rHBsAg-1018 ISS) to market, but it could require a more robust postmarketing plan than it has initially proposed to the US FDA.
Heplisav Seems Headed For Approval, But With More Robust Postmarketing Study
Safety of Dynavax's hepatitis B vaccine gets thumbs up from US FDA advisory committee, but panel remained concern that postmarketing proposal doesn't address questions about potential link to cardiovascular events.
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
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