August 29, 2011

The Food and Drug Administration has approved a new cancer drug made by Pfizer, the drug maker said.

August 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

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 11, 2011

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

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.

July 25, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

July 19, 2011

The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

July 18, 2011

Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

July 15, 2011

The World Health Organization on Thursday announced 11 new manufacturers of the seasonal flu vaccine, a development that is expected to double the number of influenza doses to 1.7 billion worldwide by 2015, according to published reports.

June 22, 2011

ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

June 21, 2011

The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

June 20, 2011

Last month, the Food and Drug Administration approved Tradjenta (linagliptin), an oral Type 2 diabetes drug made by German drug maker Boehringer Ingelheim and Indianapolis-based Eli Lilly. The drug belongs to the class known as dipeptidyl peptidase-4 inhibitors, which also includes Merck’s Januvia (sitagliptin). With diabetes affecting some 26 million Americans and growing rapidly, Drug Store News spoke with Wa’el Hashad, BI’s VP cardiovascular and metabolic disorders marketing, about what the approval of Tradjenta means for the diabetes market.


June 16, 2011

Unilever's offer to shed some of its bar soap business to win United Kingdom competition approval for its acquisition of hair and personal care products manufacturer Alberto Culver was accepted by the U.K. Office of Fair Trading.

June 8, 2011

The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

June 7, 2011

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

May 23, 2011

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

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

April 26, 2011

The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

April 25, 2011

Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

April 25, 2011

SUPPLIER NEWS — Hi-Tech Pharmacal announced the tentative approval by the Food and Drug Administration of levofloxacin oral solution in the 25-mg/mL strength, a generic antibiotic. Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin, which had sales of $6 million in 2010, according to IMS Health. Hi-Tech expected to receive final approval in June, when Johnson & Johnson’s patent expires.


April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

April 11, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

April 5, 2011

The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

March 28, 2011

The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.