The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.
Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.
FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions
FDA is taking steps to modernize the agency’s inspections program
FDA authorizes emergency use of first Ebola fingerstick test with portable reader
The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.
FDA approves new version of OTC Primatene Mist inhaler to treat mild, intermittent asthma for people who have been diagnosed with asthma by their physician
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.
FDA announces approval of Dsuvia and new steps the agency may be taking to evaluate opioids.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.
Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks
Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program report release on radiofrequency energy exposure
FDA warns consumers about concerns with pharmacogenetic tests whose claims have not been reviewed by FDA