Eli Lilly says it is discontinuing its Phase 3 development program for JAK inhibitor Olumiant (baricitinib) in adults with active systemic lupus eryth...
Joining Incyte in withdrawing an NDA over a confirmatory study disagreement, Regeneron Pharmaceuticals and Sanofi withdraw their supplemental BLA for ...
FDA commissioner nominee Robert Califfs chances of passing a Senate vote narrow as he reportedly loses some Senate backing and the White House has bee...
Federal Register notice: FDA makes available a draft guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeling.
Federal Register notice: FDA makes available a final guidance entitled Information Requests and Discipline Review Letters Under GDUFA.
A Congressional Budget Office report says that although consumer use of prescription drugs has increased between 2009 and 2018, average spending on dr...
FDA releases an FDA-483 and EIR from a 2019 inspection at Winnipeg, Manitoba-based Emergent BioSolutions Canada.
FDA cautions Hopkinton Drugs about deficiencies in its practices for producing drug products that put patients at risk.