Press Announcements
Note: Press announcements from 2004 to 2014 are available through the FDA.gov Archive. Some links in press announcements may no longer be active. For more information, contact FDA’s Office of Media Affairs at 301-796-4540.
September 2017
- September 26, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities
- September 26, 2017 - Federal judge orders Flawless Beauty to stop distributing unapproved drugs, recall certain products
- September 26, 2017 - FDA selects participants for new digital health software precertification pilot program
- September 25, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico
- September 25, 2017 - FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
- September 22, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricanes Harvey and Irma
- September 22, 2017 - Criminal and civil actions filed against Aegerion Pharmaceuticals Inc.
- September 20, 2017 - FDA clears first duodenoscope with disposable distal cap
- September 20, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction
- September 14, 2017 - FDA approves new treatment for adults with relapsed follicular lymphoma
- September 14, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms
- September 14, 2017 - FDA approves first biosimilar for the treatment of cancer
- September 14, 2017 - FDA permits marketing of mobile medical application for substance use disorder
- September 07, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
- September 01, 2017 - FDA clears mammography device with option for patient-assisted compression
- September 01, 2017 - FDA approves Mylotarg for treatment of acute myeloid leukemia
August 2017
- August 31, 2017 - Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
- August 30, 2017 - FDA approval brings first gene therapy to the United States
- August 29, 2017 - FDA approves new antibacterial drug
- August 29, 2017 - FDA approves first U.S. treatment for Chagas disease
- August 28, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
- August 28, 2017 - FDA warns US Stem Cell Clinic of significant deviations
- August 28, 2017 - FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients
- August 25, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty
- August 21, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluating prescription opioid medications approved to treat cough in children
- August 17, 2017 - FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection
- August 17, 2017 - FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia
- August 11, 2017 - FDA warns of potential contamination in multiple brands of drugs, dietary supplements
- August 08, 2017 - FDA to expand public education campaign to focus on prevention of youth e-cigarette use
- August 04, 2017 - Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions
- August 03, 2017 - FDA approves Mavyret for Hepatitis C
- August 03, 2017 - FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia
- August 02, 2017 - FDA approves treatment for chronic graft versus host disease
- August 01, 2017 - FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia
July 2017
- July 28, 2017 - FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
- July 20, 2017 - FDA clears first neonatal magnetic resonance imaging device
- July 19, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation
- July 18, 2017 - FDA approves Vosevi for Hepatitis C
- July 17, 2017 - FDA approves new treatment to reduce the risk of breast cancer returning
- July 13, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse
- July 13, 2017 - Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests
- July 07, 2017 - FDA approves new treatment for sickle cell disease
- July 06, 2017 - Federal judge enters consent decree against Alabama compounder Medistat
- July 03, 2017 - FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
June 2017
- June 30, 2017 - Federal judge orders New York smoked fish company to stop sales due to food safety violations
- June 29, 2017 - FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
- June 29, 2017 - FDA unveils plan to eliminate orphan designation backlog
- June 27, 2017 - FDA Tackles Drug Competition to Improve Patient Access
- June 26, 2017 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs
- June 22, 2017 - FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease