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FDA grants Astellas Pharma and Pfizer a priority review for their supplemental NDA for Xtandi (enzalutamide) for treating men with...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for Patent Term Restoration; Due Diligence Peti...[ Price : $8.95]
BioElectronics files a 510(k) that seeks expanded clearance for its ActiPatch Musculoskeletal Pain Therapy for adjunctive treatmen...[ Price : $8.95]
Endo and Allergan agree to pay $15 million to settle a suit by two Ohio counties accusing several drug companies and drug distribu...[ Price : $8.95]
Sen. Gary Peters asks FDA acting commissioner Ned Sharpless to answer questions on the agencys current and future efforts to addre...[ Price : $8.95]
FDA warns Polymer Technology Systems about multiple violations in its manufacturing of in vitro diagnostic medical devices.[ Price : $8.95]
FDA warns TG United about CGMP and other violations in its production of finished drugs.[ Price : $8.95]
Federal Register notice: FDA announces a 10/16 Advisory Committee meeting to review a Shionogi NDA for antibiotic for urinary trac...