Awareness Corp. of Mesa, AZ, is recalling its 7.4 ounce container of Boost Tea because it may 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. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting […]
The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC.
The U.S. Food and Drug Administration today allowed marketing of a one-time use contact lens that may help practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP). Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma.
The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer […]
Maytag Blue Cheese has been voluntarily recalled from 17 Schnuck Markets locations due to possible contamination with Listeria monocytogenes. The potential for contamination was discovered after testing by the State of Iowa at Maytag Dairy Farms, Inc., Newton Iowa, revealed the presence of Listeria monocytogenes. Read The Complete Story!
Today, the United States District Court for the Eastern District of Virginia entered a consent decree of permanent injunction between the United States and Henry’s Farm, Inc., located in Woodford, Virginia, and its owner Soo C. Park, after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The […]
As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration today issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and […]
The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for […]
The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for […]
The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the […]
The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the […]
Maytag Dairy Farms is expanding its voluntary recall of Maytag Blue blue cheese wedges, wheels and crumbles because they have the potential to be contaminated with Listeria monocytogenes. The organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Read The Complete Story!
A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes.
A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes.
FDA Statement on Senate Confirmation of Dr. Robert Califf
Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds). People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume these products. Read The […]
Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds). People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume these products. Read The […]
Maytag Dairy Farms is voluntarily recalling 5 lots of “Maytag Blue” blue cheese wedges and wheels and 15 batches of blue cheese crumbles because they have 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 […]
The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.