This week the U.S. Food and Drug Administration filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products, including sales to minors. Under the law, the FDA may pursue an NTSO against retailers that have a total of five or more repeated violations of those restrictions during compliance inspections within 36 months.
Category Archives: Food Safety News
FDA approves Yervoy to reduce the risk of melanoma returning after surgery
Today the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.
Helados La Tapatia, Inc. Recalls Products Because of Possible Allergens
Helados La Tapatia, Inc., of Fresno, California, is voluntarily recalling 13 milk based ice cream products manufactured during the limited time frame of October 8, 2015, through October 16, 2015, (see separate UPC Inventory list provided herewith for detailed description) due to the inclusion of egg and soy ingredients which were not identified on product packaging and which are potential allergens to some people.
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FDA approves first-of-its-kind product for the treatment of melanoma
The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.
FDA approves first-of-its-kind product for the treatment of melanoma
The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.
FDA approves new treatment for rare metabolic disorder
Today, the U.S. Food and Drug Administration approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).
FDA approves new therapy for certain types of advanced soft tissue sarcoma
The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
FDA approves new treatment for advanced pancreatic cancer
The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
FDA approves new drug to treat hyperkalemia
The U.S. Food and Drug Administration today approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.
US Marshals seize adulterated crab products for food safety violations
At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of Massachusetts, U.S. Marshals have seized about 5,000 cases of ready-to-eat frozen Jonah crab products processed by Rome Packing Company Inc. (Rome Packing). FDA investigators determined the products have been prepared, packed and held under unsanitary conditions and may present a risk to human health.