Dynavax (DVAX) Announces Date for FDA Panel Review of HEPLISAV-B
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Dynavax Announces FDA Advisory Committee Meeting to Review HEPLISAV-B
August 5, 2016 5:32 PM EDTBERKELEY, CA -- (Marketwired) -- 08/05/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date. HEPLISAV-B, the company's vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older, is currently under FDA review, with a... More
