FDA publishes a guidance with recommendations on using digital health technologies for remote data acquisition.
FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.
FDA requires an additional postmarketing confirmatory study for full approval of Amgens Lumakras non-small cell lung cancer treatment that obtained ac...
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.
FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death receptor-1 or program...
FDA approves a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reducing intraocular pres...
Federal Register notice: FDA withdraws approval of the indications for mantle cell lymphoma and marginal zone lymphoma for Pharmacyclics Imbruvica (ib...
Federal Register notice: FDA sends to OMB an information collection proposal entitled A Survey on Quantitative Claims in Direct-to-Consumer Prescripti...
