Dynavax Announces FDA Advisory Committee to Review HEPLISAV Dynavax Announces FDA Advisory Committee to Review HEPLISAV
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to discuss HEPLISAV at its meeting on November 14-15, 2012. Dynavax's Biologic License Application (BLA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age, is currently under review by the FDA. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review is February 24, 2013.
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