Posted by Michael Wonder on 02 Mar 2017
Dynavax announces FDA acceptance for review of its complete response to November 2016 CRL and PDUFA action date for Heplisav-B
28 February 2017 - Dynavax Technologies announced today that the U.S. FDA has accepted for review Dynavax's responses to the complete response letter issued by the FDA in November 2016 for the biologics license application for Heplisav-B, the company's vaccine candidate for immunisation against hepatitis B infection in adults 18 years of age and older.
The FDA has established 10 August 2017 as the Prescription Drug User Fee Act action date.
