The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent and reduce tobacco use among youth who identify with the hip-hop peer crowd ‒ a hard-to-reach group that is frequently exposed to pro-tobacco images and messages. The FDA’s new campaign, “Fresh Empire,” is designed to reach the approximately 6 million multicultural youth ages 12–17, specifically African American, Hispanic, and Asian American/Pacific Islander youth, who are open to smoking or are already experimenting with cigarettes.
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FDA approves new injectable drug to treat schizophrenia
On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.
FDA approves expanded indication for medical device to treat a form of brain cancer
The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.
FDA approves expanded indication for medical device to treat a form of brain cancer
The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.
K-9 Kraving Dog Food Has Announced a Voluntary Recall of Their Chicken Patties Dog Food Shipped Between July 13th – July 17th, 2015 Because The Product May Be Contaminated With Salmonella and Listeria monocytogenes
K-9 Kraving Dog 13th – July 17th, 2015 because these products may be contaminated with Salmonella and Listeria Food has announced a voluntary recall of their Chicken Patties Dog Food shipped between July Monocytogenes. Salmonella and Listeria Monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities
The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities
The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
Texas Star Nut and Food Co., Inc. Voluntarily Recalls Natural Macadamia Nuts and Simply Raw Trail Mix Due To Possible Salmonella Contamination
Texas Star Nut and Food Co., Inc. VOLUNTARILY RECALLS Nature’s Eats, Natural Macadamia Nuts 6oz and Southern Grove, Simply Raw Trail Mix 8oz. The above products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Dean Foods of Decatur, Ind. Issues Allergy Alert On Undeclared Milk in Sunkist Frozen Mango Fruit Sorbet Bars
Dean Foods of Decatur, Indiana, is voluntarily recalling Sunkist brand Frozen Mango Fruit Sorbet Bars because these products may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA approves Keytruda for advanced non-small cell lung cancer
The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.