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...
Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices: Current Good Manufacturing Practice Quality Syste...