Sens. Grassley and Warren urge FDA to quickly voice its support for including a device identifier on Medicare claims forms.
After reporting favorable study data in those aged 50-59 years, GSK says it will seek FDA approval for an expanded use of Arexvy (respiratory syncytia...
Federal Register notice: FDA sends to OMB an information collection revision entitled Standardized Reporting Forms for FDA Federally Funded Public Hea...
Three developers of the Intarcia Therapeutics ITCA 650 drug-device implantable product to improve glycemic control accuse CDER officials of making err...
FDA publishes a draft guidance describing its process for requesting and conducting voluntary remote interactive evaluations of some drug and bioresea...
FDA approves Medinols EluNIR-PERL drug-eluting stent for treating coronary artery disease.
FDA clears a Denti.AI 510(k) for its Denti.AI Detect, which is described as a state-of-the-art imaging solution engineered to aid dental professionals...
Florida officials ask a federal court to give FDA a bit longer to decide whether to approve a state plan to import some drugs from Canada for use in g...
