July 16, 2012

A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

July 13, 2012

The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

July 13, 2012

Nearly 200 drugs for mental illnesses are under clinical development or under review by the Food and Drug Administration, the largest lobbying group for the drug industry said Thursday.

July 12, 2012

The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

July 12, 2012

A clinical trial of a drug for schizophrenia did not yield the desired results, the drug's developer said.

July 10, 2012

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

July 6, 2012

The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

July 5, 2012

Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

June 15, 2012

Upsher-Smith wins 2012 DIANAs in Branded Pharmaceutical Product Manufacturer and Consumer Product Manufacturer categories.

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

June 11, 2012

Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

May 24, 2012

Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.

May 24, 2012

A drug used to treat Type 2 diabetes produced significant reduction in blood sugar in African-American patients, according to results of a late-stage clinical trial.

May 24, 2012

The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don't take their drugs as prescribed, or don't take them at all.

May 22, 2012

Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker's plans to seek approval for a nail fungus treatment.

May 17, 2012

More than 80% of health plans would require a drug manufacturer to demonstrate a clear clinical benefit compared with current branded and generic treatments in order for its drug to be placed in the plan's formulary, according to a new survey.

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 9, 2012

Seattle Genetics and Takeda's cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.

May 7, 2012

Drug maker Purdue Pharma has introduced a new educational resource for healthcare professionals designed to curb the abuse of prescription drugs, the company said Monday.

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 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.

April 26, 2012

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