FDA Alerts
FDA Clears System to Reduce Stroke Risk during Stent and Angioplasty Procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries.
FDA Approves First Tissue Adhesive for Internal Use
The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use.
Yanhee Slim Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Yanhee Slim, a product promoted and sold for weight loss on various websites.
FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
FDA to Strengthen Review of AEDs
The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.
First Drug Approved to Treat Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system.
FDA Approves Generic Version of Nexium
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older.
New Rx Approved for Low Blood Calcium
The U.S. Food and Drug Administration approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States.
FDA Approves Meningococcal Disease Vaccine
The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
FDA Approves New Psoriasis Rx
The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.