September 29, 2011

The Food and Drug Administration has declined to approve a vaccine developed by GlaxoSmithKline, the drug maker said.

September 29, 2011

Last year, U.S. Customs and Border Protection seized $5.6 million worth of illegal pharmaceutical products, a 170% increase over 2005. Meanwhile, global sales of counterfeit medicines were estimated to be more than $75 billion last year, 90% more than in 2005. In response, Pfizer and the National Association of Boards of Pharmacy announced Thursday the launch of an effort to educate patients on how to safely buy medicines online and about the risks of counterfeit drugs.

September 29, 2011

Roche has received approval from the Food and Drug Administration for its new generation of blood-glucose test strips.

September 28, 2011

Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

September 27, 2011

Lannett has received regulatory approval from the Food and Drug Administration for its version of an antipsychotic treatment.

September 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis in children.

September 23, 2011

The Food and Drug Administration has approved a treatment made by Alexion Pharmaceuticals for a rare blood disorder that affects children.

September 22, 2011

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

September 22, 2011

Epinephrine inhalers will not be made or sold after Dec. 31, and patients using them should get new prescriptions to replace them, the Food and Drug Administration said Thursday.

September 21, 2011

Researchers at the University of California Los Angeles said they have found a possible link between two new drugs for Type 2 diabetes and cancers of the pancreas and thyroid, according to a new study published in the journal Gastroenterology.

September 20, 2011

Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

September 20, 2011

The Food and Drug Administration has approved a generic version of a deep vein thrombosis treatment.

September 19, 2011

The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

September 15, 2011

The Food and Drug Administration has approved a generic drug for epilepsy made by Lupin Pharmaceuticals, the drug maker said.

September 14, 2011

A recent federal court ruling could have big implications for compounding pharmacies.

September 13, 2011

Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

September 12, 2011

The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

September 12, 2011


As the clock winds down on the patent exclusivity of the industry’s biggest blockbuster drug in November, speculation continues to grow that Pfizer will look to flip the switch on an OTC version of Lipitor (atorvastatin) before generic competition whittles away at the $7 billion behemoth. 


September 12, 2011

The issue of patent settlements, their effect on drug prices and availability, and by extension their legality has been around for a long time and will likely remain an issue for years to come. But according to a report released in May by the Federal Trade Commission, the settlements have been on the rise, increasing from 16 in 2009 to 31 in 2010.


September 12, 2011

Genentech has applied for Food and Drug Administration approval of a drug for treating skin cancer, the drug maker said Monday.

September 12, 2011

While settlements constitute the most prominent patent-related issue for generic drugs, two others have cropped up this year as well.


September 12, 2011

At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.


September 9, 2011

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

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.