FDA approves a Sanofi and Regeneron Pharmaceuticals supplemental BLA for a once-monthly, 300 mg dose of Praluent (alirocumab) injection for treating a...
Critics say that Scott Gottliebs efforts to help Cephalon obtain more fentanyl in 2006 when he was an FDA deputy commissioner shows that he is too clo...
A Massachusetts federal judge refuses to dismiss an argument from two medical practices that FDA was reckless in failing to act sufficiently against N...
FDA clears a Diazyme Laboratories 510(k) for the Procalcitonin assay for use in diagnosing sepsis.
Federal Register notice: FDA announces a 5/17 Vaccines and Related Biological Products Advisory Committee meeting.
Thermo Fisher Scientific and SpeeDx agree to develop and submit for FDA clearance the ResistancePlus MG Test for detecting M. genitalium, a rapidly gr...
Apotex petitions FDA to impose stricter approval requirements for applicants seeking approval for a biosimilar product referencing Amgens Neulasta (pe...
FDA approves Sanofis Thymoglobulin [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression to prevent acute reje...