FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at riskDecember 6, 2019
Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.December 6, 2019
FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseasesDecember 5, 2019
FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to healthNovember 27, 2019
California-based food manufacturer agrees to stop production after repeated food safety violationsNovember 26, 2019
FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infectionNovember 25, 2019
FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concernsNovember 25, 2019
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficientNovember 25, 2019
Statement on new steps to advance innovation in medical device sterilization with ethylene oxideNovember 25, 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemiaNovember 21, 2019
Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar productNovember 16, 2019
FDA approves first contact lens indicated to slow the progression of nearsightedness in childrenNovember 15, 2019
FDA approves first targeted therapy to treat patients with painful complication of sickle cell diseaseNovember 15, 2019
FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfectionNovember 15, 2019
FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistanceNovember 14, 2019
FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkageNovember 14, 2019
