A new high-pressure ventilator developed by NASA engineers and tailored to treat coronavirus (COVID-19) patients today was approved by the Food and Drug Administration (FDA) for use under the FDA’s March 24 ventilator Emergency Use Authorization. Called VITAL (Ventilator Intervention Technology Accessible Locally), the device was developed by engineers at NASA’s Jet Propulsion Laboratory (JPL) […]
FDA approves mavyret for children, adolescents with hep C
(HealthDay)—Mavyret (glecaprevir and pibrentasvir) tablets are now approved to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17 years, the U.S. Food and Drug Administration announced yesterday. The FDA approved Mavyret to treat HCV in adults in 2017. This new approval marks the first treatment option for all HCV […]
FDA approves first immunotherapy drug for breast cancer
(HealthDay)—The U.S. Food and Drug Administration has given its blessing to the first immunotherapy regimen for breast cancer. The combination of immunotherapy (Tecentriq) and chemotherapy (Abraxane) was given accelerated approval for triple-negative breast cancer that is locally advanced or has metastasized, cannot be surgically removed, and is programmed death-ligand 1-postive, CNN reported. A study published […]
FDA Warns Against Vitamins and Supplements Falsely Claiming to Prevent and Cure Alzheimer’s – GoodRx
At this time, the FDA has found that 58 products are misbranded as preventing or treating Alzheimer’s and has taken action against 17 companies in total. Most of these products are being sold as dietary supplements and are available online via websites and social media platforms. What products are included in this warning? Popular dietary […]
FDA Warns of Rare Stroke Risk With Multiple Sclerosis Drug
WEDNESDAY, Dec. 5, 2018 — A new warning has been added to the multiple sclerosis drug Lemtrada (alemtuzumab) after rare reports of patients suffering strokes and tears in the lining of the arteries in the head and neck, the U.S. Food and Drug Administration said. Most patients with these issues developed symptoms within a day […]
FDA: Safe to Eat Romaine Lettuce Again, but Check Labels
TUESDAY, Nov. 27, 2018 — In a statement released late yesterday, the U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., announced that the agency was lifting its advisory against eating romaine lettuce, first put in place last Tuesday. At that point, the agency had not been able to narrow down the source of the […]
Men Should Avoid ‘Rhino’ Sexual Enhancement Products, FDA Says
TUESDAY, Nov. 27, 2018 — The U.S. Food and Drug Administration is warning men that “Rhino” products promising better sex may pose serious health risks. Since 2007, the FDA has identified more than 25 products marketed with variations of the name Rhino that contained hidden drug ingredients. The FDA has received reports of chest pain, […]
The FDA Found Hundreds of Supplement Brands Tainted with Rx Drugs. Most Weren’t Recalled.
Dietary supplements aren’t regulated like pharmaceutical drugs, so that means they shouldn’t contain pharmaceutical drugs. Yet over the last decade, more than 750 supplement brands have been found to be tainted with drugs — sometimes containing two or more hidden drug ingredients, a new study finds. What’s more, although the Food and Drug Administration (FDA) […]
FDA seizes documents from E-cigarette maker JUUL
(HealthDay)—Thousands of pages of documents were seized from the electronic cigarette (e-cigarette) maker JUUL by the U.S. Food and Drug Administration during a surprise inspection last week as part of the agency’s investigation into the company’s marketing practices. JUUL controls 73 percent of the e-cigarette market and has come into the FDA’s crosshairs as teen […]
FDA Approves New Drug for Antibiotic-Resistant Lung Disease
MONDAY, Oct. 1, 2018 — Arikayce (amikacin liposome inhalation suspension) has been approved by the U.S. Food and Drug Administration to treat lung disease caused by Mycobacterium avium complex (MAC) bacteria among patients who do not respond to conventional therapies, the FDA said in a news release. MAC bacteria are commonly found in water and […]