A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in the consent decree.
Category Archives: Drug Safety Information Podcasts
FDA approves first-of-kind device to treat obesity
The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
FDA approves anti-clotting drug Savaysa
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
FDA grants first CLIA waiver for nucleic acid-based flu diagnostic test
The U.S. Food and Drug Administration today granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories.
FDA grants first CLIA waiver for nucleic acid-based flu diagnostic test
The U.S. Food and Drug Administration today granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories.
FDA approves weight-management drug Saxenda
The U.S. Food and Drug Administration today approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
FDA Commissioner Margaret A. Hamburg’s statement on FDA’s blood donor deferral policy for men who have sex with men
The U.S. Food and Drug Administration is a science-based regulatory agency that works to protect and promote the public health. In this role, it is our responsibility to regulate the blood supply and to help ensure its continued safety for the patients who receive these life-saving products.
FDA approves Opdivo for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.
FDA approves Opdivo for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.
FDA approves Rapivab to treat flu infection
On December 19, the U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults.