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Home » FDA Extends Dynavax’s HEPLISAV-B PDUFA by 3 Months
FDA Extends Dynavax’s HEPLISAV-B PDUFA by 3 Months
The FDA has extended the PDUFA date of Dynavax’s investigational hepatitis B vaccine Heplisav-B by three months to review new data in the company’s resubmitted BLA.