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.
December 2016
- December 23, 2016 - FDA approves first drug for spinal muscular atrophy
- December 21, 2016 - FDA permits marketing of new tissue expander for women undergoing breast reconstruction following mastectomy
- December 20, 2016 - FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions
- December 19, 2016 - FDA grants accelerated approval to new treatment for advanced ovarian cancer
- December 14, 2016 - FDA approves Eucrisa for eczema
- December 14, 2016 - FDA Statement from Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, on new safety information on anesthesia use in young children and pregnant women
- December 14, 2016 - FDA takes action on applications seeking to market modified risk tobacco products
- December 13, 2016 - FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
- December 09, 2016 - FDA takes action against four tobacco manufacturers for illegal sales of flavored cigarettes labeled as little cigars or cigars
- December 07, 2016 - FDA takes steps to improve hearing aid accessibility
- December 02, 2016 - FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes
November 2016
- November 30, 2016 - Food regulators seize adulterated milk products for food safety violations
- November 17, 2016 - FDA research to help speed development of Zika virus vaccines and therapeutics
- November 17, 2016 - FDA approves Intrarosa for postmenopausal women experiencing pain during sex
October 2016
- October 28, 2016 - FDA approves new device for prevention of recurrent strokes in certain patients
- October 19, 2016 - FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma
- October 17, 2016 - FDA awards 21 grants to stimulate product development for rare diseases
September 2016
- September 30, 2016 - FDA warns against the use of homeopathic teething tablets and gels
- September 29, 2016 - FDA Statement from Todd Simpson, FDA Chief Information Officer (CIO) on GAO Report Regarding FDA’s IT Security Program
- September 28, 2016 - FDA approves first automated insulin delivery device for type 1 diabetes
- 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