Tag: FDA

U.S. regulators moved to discipline vaping companies for inappropriately promoting their flavored nicotine formulas through so-called influencers on Facebook, Twitter and other social media sites. The Food and Drug Administration sent warning letters Friday to four companies that used paid social media influencers to pitch nicotine solutions to their online followers, including flavors like Watermelon

THURSDAY, Jan. 31, 2019 — The first generic version of the widely used Advair Diskus inhaler for asthma and chronic obstructive pulmonary disease (COPD) has won U.S. Food and Drug Administration approval. This approval “is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives,” said Dr. Janet Woodcock, director of

(HealthDay)—The U.S. Food and Drug Administration is implementing a number of steps for long-term safety monitoring of the permanent birth control device Essure, which will no longer be sold or distributed in the United States after Dec. 31, 2018. Device maker Bayer announced in July that it would halt sales due to declining use of

(HealthDay)—The U.S. Food and Drug Administration on Friday expanded approval for the use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with specific types of peripheral T-cell lymphoma (PTCL). The FDA stated in a press release that this approval is the first for treatment of newly diagnosed PTCL. Adcetris, a monoclonal

FRIDAY, Nov. 9, 2018 — As part of the U.S. Food and Drug Administration’s efforts to reduce teens’ use of flavored electronic cigarettes, a ban on sales of most flavored e-cigarettes in retail stores and gas stations across the United States is to be introduced, according to media reports. A senior FDA official said details

For the first time in nearly two decades, the U.S. Food and Drug Administration (FDA) has approved a new flu drug for the treatment of influenza. The new medication, called Xofluza (baloxavir marboxil), joins Tamiflu and other antiviral medicines as available options for people who get sick—and want to feel better faster—this flu season. Xofluza

THURSDAY, Aug. 30, 2018 — A rare but serious genital infection known as necrotizing fasciitis of the perineum, also called Fournier’s gangrene, has been reported in some patients taking a certain class of type 2 diabetes medicine, according to the U.S. Food and Drug Administration. As a result, the FDA has ordered a new warning

The idea of a cancer warning label on coffee, which may be required under California law, has sparked a bitter debate and is now drawing criticism from the U.S. Food and Drug Administration (FDA). This week, FDA Commissioner Dr. Scott Gottlieb said that such a label would mislead consumers more than it would inform them.

TUESDAY, July 17, 2018 — A new draft guideline from the U.S. Food and Drug Administration suggests Americans could get widely used prescription medicines for cholesterol, high blood pressure, asthma, and migraine headaches without having to see a doctor. The FDA says patients could use a mobile-phone app to help determine if they’re able to

TUESDAY, July 17, 2018 — Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups, according to a research letter published in the July 17 issue of the Journal of the American Medical Association. Jeremy Puthumana, from the Yale University School of Medicine in New

MONDAY, July 16, 2018 — There have been 12 reported cases of people in the United States becoming sick after eating fresh crab meat from Venezuela, the U.S. Food and Drug Administration says. The agency said the illnesses were caused by Vibrio parahaemolyticus bacteria and advised people to avoid eating fresh crab meat from Venezuela.

The US Food and Drug Administration (FDA) has strengthened warnings for the fluoroquinolone class of antibiotics after they were found to cause mental health problems and serious blood sugar disturbances, including hypoglycaemic coma in people with diabetes. Fluoroquinolones include ciprofloxacin, levofloxacin, moxifloxacin , ofloxacin, gemifloxacin and delafloxacin, which are used to treat common bacterial infections,

(HealthDay)—The U.S. Food and Drug Administration has launched legal action to stop two stem cell clinics from providing unapproved treatments that have caused serious, long-term harm to some patients. On Wednesday, the FDA filed complaints in federal court seeking permanent injunctions against U.S. Stem Cell Clinic LLC of Sunrise, Fla., and California Stem Cell Treatment

After eight years of failed treatment for persistent atrial fibrillation (AF), Janet Szilagyi, 78 of Clayton, New Jersey, became the first patient in the United States to undergo cardiac ablation—a procedure in which an electrophysiologist will scar or destroy tissue in the heart that’s allowing incorrect electrical signals to cause an abnormal heart rhythm—using an

The standard of care for kidney cancer patients continues to improve. The U.S. Food and Drug Administration granted approval to the combination of two immunotherapy drugs, ipilimumab and nivolumab, for the treatment of metastatic kidney cancer. The results of the large, international clinical trial leading to the approval were just published the prestigious New England

(HealthDay)—The U.S. Food and Drug Administration announced Friday that it has issued tough new restrictions on the sale of dietary supplements that contain dangerously high amounts of caffeine. Supplements that contain pure or highly concentrated caffeine in powder or liquid forms are no longer permitted to be sold in bulk quantities directly to consumers, the

(HealthDay)—The lives of contact lens wearers just got a whole lot easier. On Tuesday, the U.S. Food and Drug Administration approved the first contact lenses that can act like sunglasses. A special additive automatically darkens the lenses when exposed to bright light, while they become clear again in normal or dark lighting conditions. “This contact

San Diego’s Dexcom has won regulatory approval for its latest continuous glucose monitoring system that eliminates the need for finger pricks and is nearly one-third smaller than its current wearable sensor for diabetes patients. The Food and Drug Administration this week gave the green light to Dexcom’s G6 system for delivering real time blood sugar