May 10, 2012

A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.

May 10, 2012

Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

May 9, 2012

The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

May 9, 2012

The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

May 7, 2012

The National Association of Chain Drug Stores submitted on Monday comments to the Food and Drug Administration regarding its position on the “new paradigm” for a third class of drugs.

May 4, 2012

A 30% rise in attendance at the Armada Specialty Pharmacy Summit is nothing to brush off — it's as clear an indication as any that specialty pharmacy is growing and probably poised for more growth in the near future, thanks in particular to the aging population and consequential rise in the number of people living with difficult-to-treat medical conditions.

May 4, 2012

The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

May 3, 2012

Drug maker Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat patients with deep vein thrombosis or pulmonary embolism, the company said.

May 3, 2012

Drug makers could strike big with new treatments for rare diseases, according to a new report by a market research firm.

May 2, 2012

The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

May 2, 2012

The Food and Drug Administration has approved a new treatment for a rare genetic disorder that affects 10,000 people worldwide.

April 30, 2012

Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

April 30, 2012

Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

April 30, 2012

An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

April 27, 2012

The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

April 27, 2012

A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

April 27, 2012

The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

April 27, 2012

Two companies have settled with Teva over the latter's efforts to launch a generic version of an emergency treatment for allergic reactions.

April 26, 2012

The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

April 26, 2012

The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.

April 26, 2012

Drug makers in the United States are developing nearly 300 vaccines for preventing and treating diseases, according to a new report by a drug industry trade group.

April 25, 2012

The National Community Pharmacists Association has sent a letter to a Senate committee regarding legislation that would reauthorize the Prescription Drug User Fee Act.

April 25, 2012

GlaxoSmithKline said its offer to buy Human Genome Sciences was "full and fair" Wednesday after HGS turned it down last week, according to published reports.

April 24, 2012

Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.