January 6, 2015
The U.S. Food and Drug Administration today granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories.
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January 6, 2015
Eillien’s Candies Inc. announced today that it is voluntarily recalling various sizes and brands of Walnut Pieces because some of these products may be contaminated with Salmonella. Read The Complete Story!
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January 2, 2015
Zilks Foods, LLC of Austin, TX is recalling all of its 8 ounce hummus products because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
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December 29, 2014
Jardine Foods, Inc. is voluntarily recalling Chili Mix products because they may contain undeclared peanut proteins. We were notified by one of our third party suppliers that one of the spice ingredients purchased contains peanut proteins, an allergen which is not declared on the products’ ingredient statement. Read The Complete Story!
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December 29, 2014
American Roland Food Corp. announced today the recall of Roland(R) Bruschetta from lots numbered 28 and 29 due to safety concerns. The affected product was distributed to a limited number of customers and is being recalled due to the possibility of glass in the product. Read The Complete Story!
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December 24, 2014
Happy Apples, is issuing a voluntary recall of Happy Apple Brand caramel apples with a best use by date between August 25th and November 23rd 2014, 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 […]
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December 23, 2014
Real Foods of Kent, WA is initiating a voluntary recall of 299 units of Tofu Pad Thai Bowl and 178 units of Thai Noodle Salad due to misbranding and undeclared allergens. The product contains shellfish (shrimp), a known allergen which is not declared on the product label. Read The Complete Story!
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December 23, 2014
The U.S. Food and Drug Administration today approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
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December 23, 2014
The U.S. Food and Drug Administration is a science-based regulatory agency that works to protect and promote the public health. In this role, it is our responsibility to regulate the blood supply and to help ensure its continued safety for the patients who receive these life-saving products.
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December 22, 2014
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.
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December 22, 2014
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.
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December 22, 2014
On December 19, the U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults.
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December 22, 2014
On December 19, the U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults.
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December 19, 2014
The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
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December 19, 2014
The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
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December 19, 2014
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
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December 19, 2014
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
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December 19, 2014
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
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December 19, 2014
The U.S. Food and Drug Administration yesterday approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections.
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