The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated
The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.
The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of […]
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.
La Nica Products, Inc. of Miami, FL is recalling six thousand pounds of cheese, 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 others with weakened immune systems. Although healthy individuals may suffer only short-term […]
La Nica Products, Inc. of Miami, FL is recalling six thousand pounds of cheese, 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 others with weakened immune systems. Although healthy individuals may suffer only short-term […]
Italian Gluten Free Food CL of 1899 Bushwick Avenue, Merrick, NY 11566, is recalling its 15 ounce packages of “Chef Luca’s LASAGNA AL FORNO BAKED CHEESE LASAGNA” food because they may contain undeclared egg. People who have allergies to eggs run the risk of serious or life- threatening allergic reaction if they consume these products. […]
Italian Gluten Free Food CL of 1899 Bushwick Avenue, Merrick, NY 11566, is recalling its 15 ounce packages of “Chef Luca’s LASAGNA AL FORNO BAKED CHEESE LASAGNA” food because they may contain undeclared egg. People who have allergies to eggs run the risk of serious or life- threatening allergic reaction if they consume these products. […]
The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia.
Mikawaya is issuing a voluntary recall of a limited number of Mikawaya Brand Chocolate Chocolate Mochi Ice Cream, which may inadvertently contain peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume the product. Only product labeled with UPC code of […]
A.S.K. Foods, Inc. of Palmyra, Pennsylvania is voluntarily recalling one lot of Wegmans Family Pack Food You Feel Good About Net Wt. 48 oz. (3 LB.) 1.46 KG Potato Salad because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction […]
Quality Nut Co. of Massillon, Ohio is voluntarily recalling the following products due to undeclared allergens: Read The Complete Story!
Publix Super Markets is issuing a voluntary recall for Publix Deli Artichoke and Spinach Dip due to the possibility of the product containing small glass fragments. The 16 oz. artichoke and spinach dip was sold at Publix stores in Florida, Georgia, South Carolina, North Carolina , Alabama and Tennessee with a UPC of 000-41415-15961, and […]
Fourth Street Barbecue Inc. Packing Division has initiated a voluntary recall of all lot numbers of the Save-A-Lot Pick 5 Chicken Waffle Sandwich distributed nationwide as 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 others […]
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
On May 4, 2017, the United States District Court for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Syfrett Feed Company Inc. of Okeechobee, Florida; its owner and President Charles B. Syfrett I; Vice President Melissa S. Montes De Oca; and Operations Manager Charles B. Syfrett […]
The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to […]
The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to […]