The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved by the FDA for dry eye disease.
Category Archives: Food Safety News
FDA approves first MRI-guided focused ultrasound device to treat essential tremor
The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.
Hearn Kirkwood Recalls "Evie’s Cheddar Potato Salad" Because of Possible Health Risk
Hearn Kirkwood is initiating a voluntary recall of “Evie’s Cheddar Potato Salad” because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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FDA approves Differin Gel 0.1% for over-the-counter use to treat acne
The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
FDA approves first HPV test for use with SurePath Preservative Fluid
The U.S. Food and Drug Administration today approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.
FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
Federal court orders Alabama seafood company to cease production due to food safety violations
On Tuesday, July 5, 2016, the U.S. District Court for the Southern District of Alabama entered a consent decree of permanent injunction between the United States and BEK Catering LLC. The business, owned by Billy B. Stembridge, Jr. and Kyle D. Huxen, operates as Floppers Foods selling ready-to-eat seafood products and is based in Daphne, Alabama.
FDA approves first absorbable stent for coronary artery disease
The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S.
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S.