August 19, 2011

The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

August 19, 2011

NexMed USA on Thursday received clearance from the Food and Drug Administration to market the company's first over-the-counter antifungal drug, Tolnaftate-D.

August 19, 2011

While Indian generic drug maker Ranbaxy Labs is expected by many to launch a generic version of a cholesterol drug made by Pfizer later this year, it may have to sell its rights to it if it can't win Food and Drug Administration approval in time, according to published reports.

August 19, 2011

Generic drug maker Sandoz is suing Danish drug maker Novo Nordisk over a generic version of a drug used to treat diabetes, according to published reports.

August 19, 2011

Five tobacco companies filed suit against the Food and Drug Administration challenging nine new cigarette warnings as an unconstitutional way of forcing tobacco manufacturers to disseminate the government's anti-smoking message.

August 18, 2011

Forces of Nature on Wednesday introduced its brand called Control, featuring 14 USDA-certified organic and Food and Drug Administration-registered topical medicines that target seven hard-to-treat conditions, including acne, herpes cold sores (caused by the herpes simplex virus) and scars.

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.