FDA approves a Pulmonx PMA for the Zephyr Endobronchial Valve, intended to treat breathing difficulty associated with severe emphysema.
FDA clears an Arthrosurface 510(k) to market the Patellofemoral WaveKahuna Arthroplasty System.
Federal Register notice: FDA announces a 2018 CDER and CBER staff experiential learning site visit program specific to its Quality Metrics Program.
FDA says it is stepping up pressure on drug compounding facilities, particularly those preparing topical pain creams comprised of multiple ingredients...
FDA advises health care professionals not to use BioDiagnostics Internationals Monsels Solution (ferric subsulfate 20%) because the drug product was m...
In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 9.
FDA issues a draft guidance on designing nonclinical programs for developing oncology radiopharmaceuticals.
FDA issues a guidance explaining Biosimilar User Fee Amendment changes made in the 2017 program reauthorization.