Health Problems

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 […]

Health Problems

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 […]

Health News

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 […]

Health News

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 […]

Health News

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 […]

Health News

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 […]

Health News

FDA Issues Warning on Pet Reactions to Common Flea Medicine

FRIDAY, Sept. 21, 2018 — Flea medicines protect your pet, but some animals can have serious side effects from products containing isoxazoline, U.S. health officials warn. Although most dogs and cats handle this powerful pesticide just fine, others can have severe reactions, the U.S. Food and Drug Administration said Thursday. Isoxazoline products have been associated […]