August 18, 2011

Generic drug maker Sun Pharmaceutical Industries has received regulatory approval for a drug designed to treat an enlarged prostate.

August 17, 2011

The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.

August 17, 2011

Mylan announced Wednesday that it filed with the Food and Drug Administration for approval of a generic version of a drug for migraine headaches made by Endo Pharmaceuticals.

August 16, 2011

A special group of patients who participated in a trial of a heart disease drug made by Daiichi Sankyo and Eli Lilly showed fewer heart attacks, strokes and deaths related to cardiovascular disease than patients taking a competing drug, according to an analysis of study results.

August 15, 2011

Patients taking an experimental treatment for Parkinson's disease experienced greater reduction in symptoms than those taking standard therapies, according to results of a late-stage clinical trial.

August 12, 2011

Lannett announced that it has started shipping morphine sulfate oral solution, a painkiller approved by the Food and Drug Administration in June.

August 11, 2011

The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.

August 11, 2011

The Food and Drug Administration has acknowledged the resubmission of an investigational Type 2 diabetes drug made by Amylin Pharmaceuticals, Eli Lilly and Alkermes.

August 11, 2011

Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.

August 10, 2011

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

August 10, 2011

The Food and Drug Administration has granted tentative approval to a generic cholesterol drug made by Watson Pharmaceuticals, the company said Wednesday.

August 9, 2011

The Food and Drug Administration has approved a generic chemotherapy drug made by Hospira, the drug maker said.

August 8, 2011

Boston Therapeutics is seeking approval for a generic version of a pill for Type 2 diabetes, the drug maker said.

August 8, 2011

The Food and Drug Administration has accepted an approval application for a drug made by Teva Pharmaceutical Industries for treating allergies, Teva said.

August 4, 2011

The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

August 4, 2011

The world's top-selling drug may become available over the counter, if its manufacturer has its way, according to published reports.

August 4, 2011

GlaxoSmithKline company Stiefel announced it is seeking approval for a facial acne treatment in patients ages 12 years and older.

August 3, 2011

Five trade associations representing the dietary supplement industry on Wednesday collectively requested a time extension to provide comments concerning the recent draft guidance on new dietary ingredient notifications that was recently issued by the Food and Drug Administration.

August 2, 2011

The Food and Drug Administration has approved an opioid painkiller made by Covidien's generic drug division, the medical supply company said.

August 2, 2011

The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker's U.S. subsidiary said Monday.

August 2, 2011

The Food and Drug Administration has given tentative approval to an emergency treatment for severe allergic reactions made by Intelliject, the drug maker said.

August 2, 2011

The Food and Drug Administration last week issued a warning letter to Terry Harris of HBB — makers of the controversial Lazy Larry and Lazy Cakes melatonin-spiked brownies — alerting Harris that HBB's products are adulterated with an unapproved food additive.

August 2, 2011

The Food and Drug Administration is looking for comments from consumers, the food industry and others about proposed labeling for gluten-free foods.

August 2, 2011

The Food and Drug Administration on Friday warned U.S. consumers not to use the emergency birth control medicine labeled as Evital, as it may be a counterfeit version of the “morning after pill” and may not be safe or effective in preventing pregnancy.