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...
FDA updates its Risks and Complications of Breast Implants Web page that clarifies information about implant removal and adds ultrasound as an accepta...
FDA posts a draft guidance entitled Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.
FDA investigators cite five GMP issues during a September inspection at Modernas primary facility in Norwood, MA, according to a Reuters report.
