A federal judge has granted the U.S. Food and Drug Administration a permanent injunction against Truman J. Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.
At the request of the U.S. Food and Drug Administration, U.S. Marshals recently seized dietary supplements and unapproved drugs from Confidence, Inc., of Port Washington, N.Y.
The U.S. Food and Drug Administration today approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy ages 12 years and older.
The U.S. Food and Drug Administration today expanded the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
On Oct. 17, the U.S. Food and Drug Administration approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.
The U.S. Food and Drug Administration today launched a national campaign to raise public awareness about the prevalence of fraudulent Internet pharmacies, which can be dangerous to patient health, and to help consumers make safe purchases.
The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.
The U.S. Food and Drug Administration today approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted just under the skin (subcutaneously) instead of connected directly into the heart.
The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
The U.S. Food and Drug Administration today announced the formation of an internal task force that will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency.
The FDA’s top priority is ensuring the safety of our food supply. The FDA, the Centers for Disease Control and Prevention (CDC) and state and local public health officials are investigating a multi-state outbreak of Salmonella Bredeney infections possibly linked to Trader Joe’s Valencia Creamy Salted Peanut Butter, with a Stock Keeping Unit (SKU) identifier […]
The U.S. Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a health care provider.
The U.S. Food and Drug Administration today approved the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.
Full data collection to be complete by end of 2012, agency prioritizes further assessment to provide scientific basis for additional recommendations
The FDA is warning consumers against eating mangoes from Agricola Daniella, a mango supplier with multiple plantations and a single packing house located in Sinaloa, Mexico. Testing by the FDA has found Salmonella in mangoes from this producer.
he U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).
The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.
The U.S. Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.