The FDA approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.
Category Archives: Food & Drug Recalls
Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk
FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.
Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein
Jay Robb Enterprises is recalling Jay Robb Unflavored Egg White Protein Product,
manufactured by Agropur MSI, LLC of La Crosse, Wisconsin, because it may contain
undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the
risk of serious or life-threatening allergic reaction if they consume these products.
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Roche Diagnostics to Replace CoaguChek® XS PT Test Strips
Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.
The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk
The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.
Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches
Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
Recall of Green Cedar Dairy Ackawi Cheese Bearing a Sell by Date of March 26, 2019 or Later
Routine samples of the Green Cedar Ackawi cheese collected and tested by the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes.
FDA approves new drug to treat travelers’ diarrhea
FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry
The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
The FDA is committed to making sure post-market studies are transparent to the public and that industry is fulfilling their PMRs and PMCs.