The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.
The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, […]
Fatima Brothers Inc. of Maspeth, NY is recalling its 7 oz. and 14 oz. packages of “SHAD RAISINS” because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. Read The Complete Story!
The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum […]
Kermit, Inc. of DeLand, Florida issuing a voluntary recall of the following products because of undeclared allegens on the label. Undeclared soy, an ingredient in Worcestershire Sauce, is used to make the following: Read The Complete Story!
U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction on Sept. 25, 2015, against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility […]
OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 640 lbs. of Chicken, Fish & Produce Raw Frozen Canine Formulation. This is being done in an abundance of caution, as the product has the potential to be contaminated with Salmonella. Read The Complete Story!
Truco Enterprises is recalling select packages of 18 oz. On The Border Café Style Tortilla Chips after notification from a supplier that select product may have been exposed to a milk-containing ingredient. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these […]
Western Milling announced today that it has voluntarily recalled 50 lb bags of Western Blend horse feed, LOT 5251, manufactured on September 8, 2015. This voluntary recall was initiated by Western Milling after it learned that an ingredient in the feed in question may contain monensin, an ionophore. Read The Complete Story!
The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.
Tastee Apple, Inc., www.tasteeapple.com, issues allergy alert on undeclared peanuts in 3-ounce packages of Tastee Apples Plain Caramel Apples because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reactions if they consume these products. Read The Complete Story!
The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.
NatPets LLC, d/b/a “I and love and you,” of Boulder, CO (the “Company”), is expanding its voluntary recall of cow-boom! strips – beef gullet because the product has the potential to be contaminated with Salmonella. Read The Complete Story!
The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical […]
The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.
Today the U.S. Food and Drug Administration issued orders that will stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products – including its Camel Crush Bold brand – because the company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic […]