May 21, 2012

Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.

May 18, 2012

The Food and Drug Administration has approved a treatment for Parkinson's disease made by Actavis, the drug maker said Friday.

May 18, 2012

Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength.

May 18, 2012

Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

May 17, 2012

The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.

May 16, 2012

OraSure Technologies on Tuesday announced that the Food and Drug Administration's Blood Products Advisory Committee recommended that the OraQuick In-Home HIV test be made available without a prescription.

May 16, 2012

The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.

May 16, 2012

A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."

May 16, 2012

Watson has announced its intention to acquire Actavis, the company said. Following news reports that the U.S.-based generic drug maker would acquire Switzerland-based Actavis, Watson announced that it would buy the latter for $5.6 billion.

May 16, 2012

An experimental kidney cancer drug made by Pfizer didn't extend the time in which patients survived without their disease worsening when compared with a competing drug, according to results of a late-stage clinical trial released Wednesday.

May 15, 2012

Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

May 14, 2012

Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.

May 14, 2012

A Food and Drug Administration expert panel has recommended approval of a drug made by Gilead Sciences for treating HIV, the drug maker said Friday.

May 11, 2012

There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle.

May 11, 2012

Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

May 11, 2012

An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

May 11, 2012

As many as 74% of consumers would support a rapid, oral swab HIV test available over the counter, according to a survey released Friday by Who's Positive, a national HIV awareness organization.

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.