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 detect the FLT3 mutation in patients with AML.
Category Archives: Food & Drug Recalls
Urban Remedy Issues Voluntary Recall of Mislabeled Non-Dairy Spiced Golden Milk Due to Undeclared Allergen
Urban Remedy is voluntarily recalling Non-Dairy Spiced Golden Milk that was mislabeled as cold pressed apple juice. The products were sold in select Whole Foods Market stores in Arizona, California and Nevada and contained tree nut (cashew) allergens that were not listed on the product labels. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
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Lords Organics Recalls Ginger Powder Because Of Possible Health Risk
LORDS ORGANICS is recalling Ginger Powder Product from AGF Organic Veda, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Lords Organics Recalls Ginger Powder Because Of Possible Health Risk
LORDS ORGANICS is recalling Ginger Powder Product from AGF Organic Veda, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Phoenix Food, LLC Announces Voluntary Recall Of Dip Trio Mix Due To Possible Health Risk
Phoenix Food, LLC (the company) of Canton, Texas announced it is voluntarily recalling select Dip Trio Mixes due to the potential presence of Salmonella in the seasoning packet. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
FDA approves first treatment for a form of Batten disease
The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.
FDA approves first treatment for a form of Batten disease
The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.
FDA expands approved use of Stivarga to treat liver cancer
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade.
FDA expands approved use of Stivarga to treat liver cancer
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade.
Our Local Bounty Recalls Organic Basil Pesto With Watercress Because of Possible Health Risk
Our Local Bounty of Rogue River, Oregon is recalling 312 (8.5oz) containers of the Farming Fish brand Organic Basil Pesto with Watercress, 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 symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.