The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.
Category Archives: Food Safety News
FDA approves new treatment for chronic hepatitis C genotype 3 infections
The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
FDA approves new treatment for most common form of advanced skin cancer
The U.S. Food and Drug Administration today approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
FDA approves Technivie for treatment of chronic hepatitis C genotype 4
The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
FDA revises proposed Nutrition Facts label rule to include a daily value for added sugars
The U.S. Food and Drug Administration today proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats.
FDA approves diagnostic test to differentiate between types of HIV infection
The U.S. Food and Drug Administration today approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.
FDA Food Safety Challenge winners develop innovative technologies to detect Salmonella
The U.S. Food and Drug Administration today announced the winners of the 2014 FDA Food Safety Challenge, a prize competition to advance breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce. The grand prize winner and runner-up winner will receive $300,000 and $100,000 in prize money, respectively.
FDA authorizes use of prosthesis for rehabilitation of above-the-knee amputations
The U.S. Food and Drug Administration today authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
D&D Foods Issues Allergy Alert on Undeclared Milk and Wheat in Hy-Vee American Macaroni Salad
D&D Foods, Inc., based in Omaha, Nebraska, is recalling 3-pound containers of Hy-Vee American Macaroni Salad because they were incorrectly labeled and may contain undeclared milk and wheat (gluten). People who have an allergy or severe sensitivity to milk and wheat (gluten) run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer
The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.