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The FDA's request for more information on a planned, post-marketing study of Heplisav-B is pushing back an approval decision.
Original Article: Dynavax dips as its hep B drug faces another setbackNEXT ARTICLE
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...