The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.
FDA permits marketing of a new device for abdominal surgery
On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery.
The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.
FDA approves new orphan drug to treat a form of Gaucher disease
The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.
Henry’s Farm Inc. Expands Recall Of Soybean Sprouts Due To Possible Health Risk
Henry’s Farm Inc. is expanding the recall of its Soybean Sprouts, to include Natto Soybean Sprouts, because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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.
Asheville Company Recalls Tempeh After Tests Detect Presence Of Salmonella
Smiling Hara of Asheville is voluntarily recalling 12-ounce packages of unpasteurized soybean tempeh because of possible contamination with salmonella.
The company is recalling tempeh manufactured this year between Jan. 11 and April 11.
Smiling Hara Recalls Tempeh because of Possible Health Risk
Chad Oliphant, of Smiling Hara Tempeh has announced that the company was initiating a voluntary recall of all Smiling Hara products out of an abundance of caution. The products in question were manufactured between January 11, and April 11, 2012.
Kaytee Recalls Forti-Diet Pro Health Mouse, Rat and Hamster Because of Possible Salmonella Health Risk
Kaytee Pet Products is recalling a single manufacturing batch of Kaytee Forti-Diet Pro Health Mouse, Rat and Hamster due to possible contamination with Salmonella. The product affected by this recall is identified below and has the following “Best Before” dates
Diamond Pet Foods Expands Voluntary Recall to Include Diamond Puppy Formula due to Possible Salmonella Contamination
Diamond Pet Foods is expanding a voluntary recall to include Diamond Puppy Formula dry dog food. The company took this precautionary measure because sampling revealed Salmonella in the product.
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FDA approves new antibacterial treatment for plague
The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.
FDA approves Stendra for erectile dysfunction
The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.