Heplisav-B regulatory update

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Nov. 16 to discuss a BLA from Dynavax for Heplisav-B to prevent HBV infection in adults. The vaccine, which combines hepatitis B surface antigen (HBsAg) with a toll-like receptor 9 (TLR9) agonist, has a Dec. 15 PDUFA date. ...