Dynavax (DVAX) Announces Date for FDA Panel Review of HEPLISAV-B
- Health, energy stocks hit Wall St, Microsoft lifts Nasdaq
- AT&T (T) in Advanced Talks to Acquire Time Warner (TWX) - DJ
- Rockwell Automation (ROK) Said to Attract Takeover Interest from Schneider Electric - Source
- British American Tobacco Offers to Acquire Remaining Shares of Reynolds American (RAI) for $56.50/Share
- General Electric (GE) Tops Q3 EPS by 2c; Updates FY16 EPS Outlook
Get daily under-the-radar research with StreetInsider.com's Stealth Growth Insider Get your 2-Wk Free Trial here.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced 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 December 15, 2016 Prescription Drug User Fee Act (PDUFA) action date.
"The upcoming VBRPAC meeting is the next step towards our goal of obtaining regulatory approval for HEPLISAV-B and we are prepared for it," said Eddie Gray, chief executive officer of Dynavax. "The company looks forward to discussing HEPLISAV-B with the advisory committee and continuing to work closely with the FDA through the review process."
The VRBPAC reviews and evaluates data regarding the safety, efficacy, and appropriate use of vaccines and related biological products that are intended for use in the prevention, treatment, or diagnosis of human diseases.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Needham & Company Starts Neurocrine Bio. (NBIX) at Buy
- Dermira (DERM) Presents Data from DRM01 Phase 2b Trial
- CymaBay Therapeutics (CBAY) Announces Oral Late-Breaking Presentation of Phase 2 Proof-of-Concept Study of MBX-8025 in Patients With PBC at AASLD
Create E-mail Alert Related CategoriesCorporate News, FDA
Related EntitiesPDUFA, AdCom
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!