Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.
Category Archives: Food Safety News
FDA takes several actions involving genetically engineered plants and animals for food
Based on sound science and a comprehensive review, the U.S. Food and Drug Administration (FDA) is taking several important steps today regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon. The agency is also issuing two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from GE plants.
FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.
FDA takes action to protect consumers from potentially dangerous dietary supplements
The U.S. Food and Drug Administration, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.
FDA approves Darzalex for patients with previously treated multiple myeloma
Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.
Virginia Diner, Inc. Issues Allergy Alert on Undeclared Peanut Allergen in Pecan Turtledoves Chocolate Caramel Pecan Clusters (Candy)
Virginia Diner, Inc. is voluntarily recalling, as a precaution, 10 oz. cans of Happy Holidays Pecan Turtledoves Chocolate Caramel Pecan Clusters (Candy) at the company’s Wakefield, VA location because they may contain peanuts and peanut allergens. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA approves modified antihemophilic factor for hemophilia A
The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.
FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors
The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a Consent Decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. FDA ordered this recall under the terms of the Consent Decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
FDA approves new pill to treat certain patients with non-small cell lung cancer
Today, the U.S. Food and Drug Administration granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
FDA releases groundbreaking food safety rules for produce farms and imported food to modernize and strengthen food safety system
The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules implementing the bipartisan Food Safety Modernization Act that, for the first time, establish enforceable safety standards for produce farms, and make importers accountable for verifying that imported food meets U.S. safety standards. The Agency also issued a rule establishing a certification program for accredited entities conducting food safety audits of foreign food facilities. These final rules will help produce farmers and food importers take steps to prevent problems before they occur.