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A joint FDA advisory committee votes to recommend approval for a Takeda Pharmaceutical BLA for vedolizumab and its use in treating...[ Price : $8.95]
FDAs Seattle District Office warns Jubilant HollisterStier about CGMP violations in its manufacturing of finished pharmaceuticals....[ Price : $8.95]
PhRMA calls on FDA to issue guidance on how drug companies can disseminate healthcare economic data under FDAMA Section 114 withou...[ Price : $8.95]
AbbVie reports positive data from its SAPPHIRE-II study of a three direct-acting-antiviral regimen plus ribavirin in patients with...[ Price : $8.95]
FDA approves a Zogenix supplemental NDA for a 4 mg dose of Sumavel DosePro Needle-free Delivery System.[ Price : $8.95]
CDER Office of Compliance deputy director Ilisa Bernstein says the Center plans to place more attention on data integrity problems...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on medical device current good manufacturing practice to...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an information collection associated with submission of periodic safety reports for...