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Dynavax had said it was the last throw of the dice for its hepatitis B vaccine, Hepislav-B – the data pointed to it entering the market as best-in-class but it had received one knock-back after another, culminating in a final three month user fee action data delay.
It was first rejected in 2013 and then later in 2016, both times requiring more data on safety and post-marketing plans. In the end, the FDA agreed that the data supported an approval and it proved that persistence does pay off for Dynavax.
Original Article: Hep-B vaccine four-year battle for FDA approval is finally wonNEXT ARTICLE
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...