FDA clears a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will reduce the number of par...
FDA approves a Novartis BLA for Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis in sickle cell disease patients.
FDA approves a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older with complicated uri...
FDA issues a final guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.
FDA funds a $1.7 million two-year project in which five universities will study quality management in FDA drug manufacturing operation inspections.
Federal Register notice: FDA makes available a final guidance entitled Process to Request a Review of FDAs Decision Not to Issue Certain Export Certif...
Federal Register notice: FDA sends to OMB an information collection extension for Hypertension Indication: Drug Labeling For Cardiovascular Outcome Cl...
FDA clears an Ultromics 510(k) for its image analysis system EchoGo Core, which uses artificial intelligence to automate the analysis and quantificati...