Posted August 10, 2018
The U.S. Food and Drug Administration (FDA) had twice rejected Dynavax’s application for licensure for Heplisav-B in the past four years because of safety signals.2 In Dynavax’s third attempt, the FDA granted the license in November 2017, despite unresolved safety concerns. Below is the sequence of events leading to licensure of Heplisav-B. Read more.