Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel
Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.
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The European Medicines Agency is set to decide whether Dynavax’s “fewer dose” Heplisav-B vaccine should be authorized for use across the EU – years after the company experienced a setback with its first attempt to get the vaccine approved.
VBI’s Sci-B-Vac CONSTANT data firmly establishes the hepatitis B vaccine’s advantages over GSK’s longstanding Engerix-B, but it faces a tougher challenge with Heplisav-B from Dynavax.
The latest drug approval and development news from our US FDA Performance Tracker.