14 November 2016 - Dynavax Technologies today announced that it has received a complete response letter from the U.S. FDA regarding its biologics license application for Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)] for immunisation of adults 18 years and older against hepatitis B infection. 

The FDA issues complete response letters to communicate that the Agency has completed a review cycle of an application and to request additional information for review and approval. Dynavax expects a Class 2 designation for a resubmission of the application, which would result in a target review period of six months.

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