The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL.
Category Archives: Food Safety News
Progressive Gourment Inc. Issues an Allergy Alert on Taste of Inspirations Edamame Rangoon Due to Possible Mislabeling and Undeclared Crustacean Shellfish
Progressive Gourmet Inc. of Wilmington, MA, is voluntarily recalling its frozen, 9 ounce packages of Taste of Inspirations Edamame Rangoon out of an abundance of caution because they have the potential to contain crustacean shellfish (crab). People who have an allergy to crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns
Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue.
WD Import and Export Inc. Issues an Alert on Dried Fish Due To Possible Health Risk
WD Import and Export Inc. located at 4703 2nd Ave, Brooklyn, NY 11232 is recalling its bulk unlabeled cardboard boxes of Dried Yellow Fish because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
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FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients
The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.
FDA approves first leadless pacemaker to treat heart rhythm disorders
The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.
FDA approves first leadless pacemaker to treat heart rhythm disorders
The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.
FDA approves Inflectra, a biosimilar to Remicade
The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
FDA approves Inflectra, a biosimilar to Remicade
The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
FDA releases final rule to ensure food safety during transport
The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation. The rule will require those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.