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FDA denies an Apotex petition asking it to set requirements for BLAs referencing Neulasta, and doesnt comment on whether it may ul...[ Price : $8.95]
FDA issues three guidances explaining revised performance goal actions approved in the MDUFA 4 reauthorization for 510(k)s, PMAs, ...[ Price : $8.95]
The 9th Circuit Court of Appeals declines to rehear a whistleblower case involving three Gilead HIV drugs.[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency is making changes to make it easier for patients to gain access to experimental th...[ Price : $8.95]
Federal Register notice: An FDA advisory committee reviews a Braeburn Pharmaceuticals NDA for buprenorphine subcutaneous injection...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Dasan E&T Co. and Diasol East.[ Price : $8.95]
Federal Register notice: FDA announces a 10/18 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Novo Nor...[ Price : $8.95]
Federal Register notice: FDA joint advisory committee meeting reviews Indivior Pharmaceuticals NDA for buprenorphine subcutaneous ...