Indivior Solutions pleads guilty to one felony count and agrees to pay a total of $600 million to resolve criminal and civil liability associated with...
FDA requests additional data and manufacturing information from Solid Biosciences to potentially lift a clinical hold on the companys Phase 1-2 IGNITE...
FDA reissues an emergency use authorization to LabCorp for its Covid-19 RT-PCR Test to include two new indications for use testing for asymptomatic p...
FDA clears a Stratus Medical 510(k) for the Vesta RF Cannula for use in radiofrequency heat lesion procedures for relieving pain.
Federal Register notice: FDA proposes to establish requirements for the deadline and annual summary contents for sponsors and manufacturers under the ...
Federal Register notice: FDA seeks comments on an information collection extension for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Stud...
Federal Register notice: FDA revokes the Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Zika IgM Assay System because th...