FDA Asks for More Safety Data on Dynavax's Hepatitis B Vaccine

Source: Reuters

By: Dey, Esha


The U.S. Food and Drug Administration (FDA) has asked Dynavax Technologies for additional safety data on its experimental hepatitis B vaccine, Heplisav. The company did not secure the backing of the FDA in February due to concerns about its safety data. Dynavax’s safety database needed additional subjects. The company is also working to answer questions about the manufacturing and testing of Heplisav.

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