The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.
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FDA approves first biosimilar for the treatment of cancer
The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Natural Grocers Issues Recall on Organic Deglet Dates Due to Mislabeling and Undeclared Allergens
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen. People who have an allergy or severe sensitivity to coconut run the risk of a serious or life-threatening allergic reaction if they consume this product.
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FDA permits marketing of mobile medical application for substance use disorder
Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence.
OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters
On August 2, 2017, OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage.
Cherry Valley Marketplace Issues Allergy Alert on Undeclared Milk Allergens in “Cherry Valley Vanilla Cupcakes” and “Cherry Valley Chocolate Cupcakes”
Cherry Valley Marketplace, West Hempstead, NY, is recalling its 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES and CHERRY VALLEY CHOCOLATE CUPCAKES because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.
Medtronic Announces Voluntary Recall of Diabetes Infusion Sets
Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.
Bravo Produce Inc. Retira Maradol Papaya de Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V. Por posible riesgo a la salud
Bravo Produce Inc de San Ysidro, está retirando Maradol Papaya, cultivadas por Productores y Exportadores de Carica Papaya de Tecoman y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V., como manera preventiva, debido a que dicho producto ha probado positivo para Salmonella, es de suma importancia mencionar que dicha bacteria puede afectar a niños, ancianos y personas con sistemas inmunológicos débiles. Los síntomas a experimentar son fiebre, diarrea, náusea, vómito y dolor abdominal. En raras circunstancias, la infección por Salmonella puede resultar en el organismo entrando en el torrente sanguíneo y la producción de enfermedades graves, como las infecciones arteriales (es decir, los aneurismas infectados), endocarditis y artritis.
Coborn’s, Inc.’s Issues Recall of American Rye Bread and Caraway Rye Bread Due To Undeclared Allergens
Coborn’s, Inc. is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy and egg) as a result of an update to the ingredient profile from the manufacturer of the base. People who have an allergy or severe sensitivity to Milk, Soy, and/or Eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecomán Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk
Bravo Produce Inc. of San Ysidro, is withdrawing Maradol Papaya, grown by Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR of RL and packed by Frutas Selectas de Tijuana, S. de RL de CV, as a preventive measure, because the product has tested positive for Salmonella by exams done by FDA. It is extremely important to mention that this bacterium can affect children, elderly and people with weak immune systems. Symptoms are fever, diarrhea, nausea, vomiting and abdominal pain.
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