FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clotsMay 16, 2019
FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issueMay 15, 2019
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosisMay 13, 2019
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorderMay 13, 2019
Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implantsMay 2, 2019
Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas on steps to usher the U.S. into a new era of smarter food safetyApril 30, 2019
FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathwayApril 30, 2019
FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicinesApril 30, 2019
FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homesApril 25, 2019
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staplesApril 23, 2019
Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recallsApril 23, 2019
Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccineApril 22, 2019
FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplementsApril 16, 2019
FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to remove all devices from the marketApril 16, 2019