Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.
Category Archives: Food Safety News
FDA clears military traumatic wound dressing for use in the civilian population
Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication for use from use by the military only to use in adults and adolescents in the general population.
FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma
Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.
Blue Buffalo Voluntarily Recalls One Lot of Cub Size Wilderness Wild Chews Bones Due to Potential Salmonella Health Risk
Blue Buffalo Company is voluntarily recalling one production lot of Cub Size Wilderness Wild Chews Bones. This is being done in an abundance of caution, as the product has the potential to be contaminated with Salmonella.
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Raley’s Family of Fine Stores Issues Allergy Alert on Undeclared Cashew and Almond in Raley’s Frozen Sweet Pumpkin Ravioli
WEST SACRAMENTO, CA – Raley’s Family of Fine Stores removed Raley’s Frozen Sweet Pumpkin Ravioli 10 oz.from our Raley’s, Bel Air and Nob Hill stores on November 17, 2015. According to the manufacturer, the product may contain an undeclared cashew and almond allergen.
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FDA approves first seasonal influenza vaccine containing an adjuvant
The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.
FDA approves Portrazza to treat advanced squamous non-small cell lung cancer
The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.
FDA approves vaccine for use after known or suspected anthrax exposure
The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.
FDA approves vaccine for use after known or suspected anthrax exposure
The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.
FDA approves Opdivo to treat advanced form of kidney cancer
The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.