July 9, 2013

The Food and Drug Administration has approved a new drug for treating opioid dependence.

July 9, 2013

The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

July 8, 2013

Impax Labs has appointed Mary Pendergast to its board of directors, the generic drug maker said.

July 2, 2013

The Food and Drug Administration has approved a gel formulation of a foot fungus drug made by Merz Pharmaceuticals, according to published reports.

July 2, 2013

Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

July 1, 2013

CVS/pharmacy has bolstered its mobile app by adding the new Drug Interaction Checker, which is an industry first that allows customers to easily check for potential drug interactions by comparing OTC products with their prescriptions and other OTCs on their smartphones.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

June 27, 2013

The Food and Drug Administration has approved what's being called the first therapy of its kind to prevent bleeding episodes.

June 26, 2013

The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

June 26, 2013

Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

June 25, 2013

Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

June 21, 2013

The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

June 17, 2013

Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

June 13, 2013

The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

June 6, 2013

The Food and Drug Administration has approved a drug made by Celgene for treating a type of cancer.

June 5, 2013

South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug.

May 30, 2013

Beauty trends are as much a reflection of the consumer's state of mind as they are a reflection of the technological innovations put forth by research-and-development teams at laboratories around the world. While consumers are not able to verbalize their expectations for the ideal product that will fulfill their needs, they are able to pinpoint gaps with their unmet needs through their purchasing patterns.

May 30, 2013

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 30, 2013

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

May 29, 2013

Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

May 29, 2013

The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said.

May 23, 2013

Johnson & Johnson expects to file for Food and Drug Administration approval of more than 10 new drugs over the next four years, the drug maker said Thursday.