8/25/2014 2:06:00 PM
A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber.
8/20/2014 4:23:00 PM
Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.
8/19/2014 4:24:00 PM
The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.