The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).
The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).
King Soopers said today it has recalled its chicken salad sandwiches that are sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. The product may be contaminated with Listeria monocytogenes.
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
Silver Spring is voluntarily recalling Waterfront Bistro Tartar Sauce because there is a chance an incorrect back label was attached to the product, which does not correctly identify ingredients that could pose an allergen risk; specifically egg.
A federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.
Today, the U.S. Food and Drug Administration announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S.
As an agency dedicated to promoting public health, and as fellow Americans, the staff at the U.S. Food and Drug Administration is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. First and foremost, these efforts are focused around our mission driven responsibilities to ensure the […]
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.
America New York Ri Wang Food Group Co. ltd is recalling the following products because an allergenic ingredient, milk, was not declared in labelling. People who have an allergy or severe sensitivity to milk run the risk of serious of life-threatening allergic reaction if they consume these products.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma
Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce.
First Source of Pico Rivera, CA, is recalling Tasty Treats Nonpareils Milk Chocolate because it contains undeclared milk. People who have an allergy or severe sensitivity to Milk run the risk of serious or life-threatening allergic reaction if they consume this product.
Natures Supplement, Inc. is voluntarily recalling 260 bottles of VEGETABLE VIGRA, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for […]
Death Wish Coffee Co. (“Death Wish”), the Round Lake, N.Y.-based coffee producer known for producing the ‘World’s Strongest Coffee’, has initiated a recall its 11-oz Death Wish Nitro Cold Brew cans.
Newark, CA, Gadget Island, Inc. is voluntarily recalling to the consumer level. The products have been found to contain undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder regain […]
The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.