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 final guidance entitled Good ANDA Submission Practices.
The CDER Office of Prescription Drug Promotion says a Lilly social media post for Trulicity is false and misleading because it inadequately presents t...
Sens. Grassley and Warren urge FDA to quickly finalize its proposed rule on over-the-counter hearing aids.
Hanzo compliance product manager Will Walker says companies need interactive Web archives to be able to show FDA how consumers viewed promotional mate...
Federal Register notice: FDA makes available a draft guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeling.