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Heplisav’s Hopes For U.S. Approval Could Rest On Narrower Population

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In a “complete response” letter for the novel, adjuvanted hepatitis B vaccine, FDA cites the need for more safety data in the broad population of adults for which approval was sought; however, Dynavax says the agency appears open to considering a more restricted use, such as in patients with chronic kidney disease.

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