As part of its ongoing efforts to address the opioid epidemic, FDA releases a draft guidance to help sponsors develop medication-assisted treatments a...
FDA clears a Varian 510(k) for its Calypso Anchored Beacon transponder for treating lung tumors.
FDA allows the de novo marketing for Bruker Daltoniks Bruker Maldi Biotyper CA system for identifying C. auris.
A federal judge in Arkansas enters a consent decree of permanent injunction between FDA and drug compounder Cantrell Drug Co. and its CEO James L. McC...
Federal Register notice: FDA announces the renewal of its Arthritis Advisory Committee for an additional two years beyond the charter expiration date.
Attorney Jennifer Thomas says the FTC decision to appeal an adverse ruling in its Vancocin case against Shire demonstrates its concern with the lower ...
Federal Register notice: FDA makes available a draft guidance entitled Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Quality ...
FDA clears a SpeeDx 510(k) for its ResistancePlus MG Positive Control kit, a diagnostic test that simultaneously detects M. genitalium and genetic mar...