Press Announcements
Note: Press announcements from 2004 to 2012 are available through the FDA 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 2016
- September 23, 2016 - FDA approves expanded indications for Ilaris for three rare diseases
- September 23, 2016 - FDA approves Amjevita, a biosimilar to Humira
- September 19, 2016 - FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths
- September 19, 2016 - FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
- September 16, 2016 - FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction
- September 15, 2016 - FDA protects kids from illegal sales of e-cigarettes, e-liquids and cigars
- September 13, 2016 - FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness
- September 09, 2016 - FDA provides $21.8 million to states for FSMA produce safety rule implementation
- September 02, 2016 - FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
- September 02, 2016 - FDA issues final rule on safety and effectiveness of antibacterial soaps
August 2016
- August 31, 2016 - FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
- August 30, 2016 - FDA approves Erelzi, a biosimilar to Enbrel
- August 26, 2016 - FDA advises testing for Zika virus in all donated blood and blood components in the US
- August 22, 2016 - FDA Statement on Medical Device User Fee Agreement (MDUFA)
- August 22, 2016 - FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury
- August 18, 2016 - FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery
- August 11, 2016 - FDA updates draft guidance on premarket safety notifications for dietary supplement industry
- August 05, 2016 - FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
- August 04, 2016 - Kratom seized in California by US Marshals Service
July 2016
- July 28, 2016 - Statement from Peter Marks, M.D., Ph.D., Director, FDA’s Center for Biologics Evaluation and Research
- July 28, 2016 - FDA approves Adlyxin to treat type 2 diabetes
- July 26, 2016 - FDA updates warnings for fluoroquinolone antibiotics
- July 19, 2016 - Federal court orders Minnesota sprout and noodle company to cease operations due to unsanitary conditions
- July 15, 2016 - FDA approves first intraocular lens with extended range of vision for cataract patients
- July 12, 2016 - FDA approves new medication for dry eye disease
- July 11, 2016 - FDA approves first MRI-guided focused ultrasound device to treat essential tremor
- July 08, 2016 - FDA approves Differin Gel 0.1% for over-the-counter use to treat acne
- July 07, 2016 - FDA approves first HPV test for use with SurePath Preservative Fluid
- July 06, 2016 - FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
- July 06, 2016 - Federal court orders Alabama seafood company to cease production due to food safety violations
- July 05, 2016 - FDA approves first absorbable stent for coronary artery disease
June 2016
- June 29, 2016 - FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
- June 29, 2016 - FDA approves implantable device that changes the shape of the cornea to correct near vision
- June 29, 2016 - FDA requests additional information to address data gaps for consumer hand sanitizers
- June 29, 2016 - Statement from FDA Commissioner Robert Califf, M.D. announcing the acting director of the FDA Oncology Center of Excellence
- June 28, 2016 - FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
- June 28, 2016 - Federal Court orders California soy company to cease production due to food safety violations
- June 14, 2016 - FDA approves AspireAssist obesity device
- June 10, 2016 - FDA approves vaccine to prevent cholera for travelers
- June 09, 2016 - FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX
- June 09, 2016 - Statement on HHS OIG Early Alert on FDA food recall initiation process
- June 02, 2016 - Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form
- June 01, 2016 - FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors
- June 01, 2016 - FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
- June 01, 2016 - FDA takes action against Kansas food manufacturer for repeated food safety violations
- June 01, 2016 - FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food
May 2016
- May 31, 2016 - FDA approves Ocaliva for rare, chronic liver disease
- May 27, 2016 - FDA approves Zinbryta to treat multiple sclerosis
- May 27, 2016 - FDA approves new diagnostic imaging agent to detect recurrent prostate cancer
- May 26, 2016 - FDA approves first buprenorphine implant for treatment of opioid dependence