FDA approves a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a first-in-class non-opioid pain drug for treating moderate to severe acute pain...
Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs.
Federal Register notice: FDA sends to OMB an information collection revision entitled Biosimilars User Fee Program.
An FDA alert advises healthcare providers about Fresenius Kabis Ivenix large-volume pumps and their increased chance of issuing a non-recoverable pump...
Mercury Medical recalls its Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the requi...
FDA posts a final guidance entitled Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissue...
Senators Chuck Grassley (R-IA) and Dick Durbin (D-IL) urge the Pharmaceutical Research and Manufacturers of America to support their bipartisan Drug-p...
Inhibikase Therapeutics pauses further development of risvodetinib and its use in untreated Parkinsons disease due to disappointing Phase 2 study data...
