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FDA accepts for priority review a Bristol-Myers Squibb BLA for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhib...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Establishing That a Tobacco Product Was Commercially Marketed in the United Stat...[ Price : $8.95]
A federal appeals court deals FDA a blow, ruling that it cannot short-circuit the statutory medical device reclassification proces...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on new animal drug adverse event reporting.[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period for a draft guidance on Internet/Social Media Platforms with Character Spa...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on a draft guidance on correcting third party misinformation about drugs/d...[ Price : $8.95]
FDA says it has identified a potential safety signal with Novartis Zortress (everolimus) oral tablets, indicated for preventing ki...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period for a draft guidance on Informed Consent Information Sheet.