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.
Category Archives: Drug Safety Information Podcasts
FDA approves Kyprolis for some patients with multiple myeloma
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.
FDA approves weight-management drug Qsymia
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.
FDA approves first drug for reducing the risk of sexually acquired HIV infection
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.
FDA approves new colon-cleansing drug for colonoscopy prep
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.
FDA warns consumers about Listeria threat in Mexicali Cheese Corp. products
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.
FDA seeks to halt production, distribution of dietary supplements at NY company
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.
FDA, UC Davis, Agilent Technologies and CDC to create publicly available food pathogen genome database
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.
FDA outlines plans to provide earlier feedback on device product submissions
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.
Wisconsin livestock dealer enters into consent decree involving drug residues in cows
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.