The U.S. Food and Drug Administration is warning consumers not to eat whole cantaloupes from Burch Equipment LLC, of Faison, N.C., because of possible contamination with Listeria monocytogenes (L. mono). The company had shipped 580 cases of whole cantaloupes on July 15, which were then distributed to retail stores in New York and Maine. Consumers […]
The U.S. Food and Drug Administration today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.
• The U.S. Food and Drug Administration is warning consumers not to eat raw or partially cooked oysters and clams (shellfish) with tags listing Oyster Bay Harbor, in Nassau County, N.Y., as the harvest area, following illnesses reported in several states caused by Vibrio parahaemolyticus bacteria.
The U.S. Food and Drug Administration today approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.
The U.S. Food and Drug Administration today approved Kyprolis (carfilzomib) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy.
The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.
Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.
The U.S. Food and Drug Administration today approved Prepopik (sodium picosulfate, magnesium oxide and citric acid) to help cleanse the colon in adults preparing for colonoscopy.
The U.S. Food and Drug Administration is warning consumers not to purchase or consume any products from the Mexicali Cheese Corp. of Woodhaven, N.Y., after the bacterium Listeria monocytogenes was found in the company’s finished product.
The U.S. Food and Drug Administration is seeking an injunction requiring Kabco Pharmaceuticals Inc., and owner Abu Kabir, of Amityville, N.Y., to stop producing and distributing dietary supplements until they comply with the Federal Food, Drug and Cosmetic Act and current good manufacturing practice (cGMP) requirements for dietary supplements.
The U.S. Food and Drug Administration (FDA), the University of California, Davis, Agilent Technologies Inc., and the Centers for Disease Control and Prevention (CDC) announced today a collaboration to create a public database of 100,000 foodborne pathogen genomes to help speed identification of bacteria responsible for foodborne outbreaks.
The U.S. Food and Drug Administration today issued a draft guidance that outlines the agency’s recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting a product- or research-specific application.
A Wisconsin livestock company and its owner have entered into a consent decree of permanent injunction resulting from a complaint filed by the U.S. Department of Justice on behalf of the FDA alleging violations of federal food and drug safety requirements.
The U.S. Food and Drug Administration today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.
The U.S. Food and Drug Administration today approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the presence of a gene mutation.
The U.S. Food and Drug Administration today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved new drugs from the market.
The U.S. Food and Drug Administration today approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).