December 1, 2011

In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

December 1, 2011

Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer's cholesterol-lowering drug Lipitor.

December 1, 2011

Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

November 30, 2011

The Food and Drug Administration on Tuesday appealed a recent District Court ruling that had placed a preliminary injunction on new, graphic anti-smoking messages that were to be placed on cigarette packaging as of September 2012.

November 30, 2011

Ranbaxy Labs was supposed to launch its generic version of the world's top-selling drug Wednesday, but a competitor beat it to the punch as the former waits for final Food and Drug Administration clearance.

November 29, 2011

A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.

November 29, 2011

The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

November 28, 2011

The Food and Drug Administration has approved a generic drug made by Mylan for cancer patients.

November 28, 2011

The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

November 28, 2011

Perrigo on Monday announced that it received final approval from the Food and Drug Administration for its store-brand version of Mucinex tablets.

November 28, 2011

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

November 23, 2011

The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

November 23, 2011

The Food and Drug Administration has approved a professional glucose monitoring system made by Medtronic, the company said.

November 23, 2011

British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.

November 21, 2011

A drug made by Amgen delayed the spread of prostate cancer to the bones in men with the disease and prolonged the survival of men with the condition, according to results of a late-stage clinical trial.

November 21, 2011

After being unanimously recommended for approval by a Food and Drug Administration panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals.

November 21, 2011

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

November 18, 2011

The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.

November 18, 2011

A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

November 16, 2011

The Food and Drug Administration has approved a new drug for treating a rare bone disease, the agency said Wednesday.

November 16, 2011

The Food and Drug Administration has approved a new insulin-delivery system for Type 1 diabetes made by Tandem Diabetes Care, the company said Wednesday.

November 15, 2011

Perrigo on Tuesday announced it received Food and Drug Administration clearance to market and distribute infant formula that contains 100% partially hydrolyzed whey protein.

November 14, 2011

The Food and Drug Administration has approved a generic drug for treating pain.

November 11, 2011

Watson Pharmaceuticals is challenging Swiss drug maker Novartis' patent on a drug used to treat dementia, Watson said.