Tag: resubmit-its

Dynavax Technologies Corp said its experimental hepatitis B vaccine was found to be safe and effective in a late-stage study, paving the way for the company to resubmit its marketing application. The earlier marketing application for the vaccine, HEPLISAV-B, was rejected in February 2013 by the U.S. Food and Drug Administration (FDA), which sought additional…

Dynavax Technologies Corp said its experimental hepatitis B vaccine was found to be safe and effective in a late-stage study, paving the way for the company to resubmit its marketing application. The earlier marketing application for the vaccine, HEPLISAV-B, was rejected in February 2013 by the U.S. Food and Drug Administration (FDA), which sought additional…