Lilly says its pancreatic cancer drug misses its primary endpoint in a Phase 3 trial.
HHSs Office of Inspector General says it is assessing FDAs medical device postmarket surveillance activities.
ViiV Healthcare submits a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection.
A CDRH Webinar discusses issues seen in dental device 510(k) submissions and ways in which they can be improved.
FDA approves a TerSera Therapeutics NDA for Quzyttir (cetirizine hydrochloride) injection for treating acute urticaria in adults and children.
FDA issues a safety alert on Efficient Laboratories Rompe Pecho EX and Rompe Pecho CF cough syrups due to microbial contamination risks.
Federal Register notice: FDA seeks comments on an information collection extension entitled Potential Tobacco Product Violations Reporting Form.
FDA drug reviewers raise mortality concerns with a Shionogi urinary infection NDA for cefiderocol injection that heads to an advisory committee vote.