August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

August 8, 2013

The urgency behind Diplomat's launch of its Retail Specialty Network isn't hard to fathom. As the growth momentum in pharmaceuticals shifts from traditionally developed drugs to more complex and expensive specialty and biotech products, traditional pharmacies without access to these specialized medicines — and the patients who depend on them — find themselves stranded in a receding market like boats at low tide.

August 6, 2013

Actavis has acquired global rights to a drug made by a Spanish company for fungal infections of the vagina, the companies said Tuesday.

August 5, 2013

The Food and Drug Administration has approved for shipment the latest version of a GlaxoSmithKline flu vaccine, the drug maker said Monday.

August 5, 2013

A new treatment for bacterial infections of the vagina is now available, the drug's manufacturer said.

August 2, 2013

The Food and Drug Administration has approved a vaccine against meningococcal disease for use among patients of a broader age range than before.

August 2, 2013

Novo Nordisk is offering $80,000 to diabetes-education programs in a Minnesota city, the Danish drug maker said Friday.

August 2, 2013

The Senate was expected to take up a bill designed to secure the drug supply chain and establish a list of "do not compound" medications, but left for recess Friday without voting on it.

July 31, 2013

Nearly 450 drugs are under development for treating neurological disorders, according to a report by a drug industry trade group.

July 29, 2013

Actavis is launching new formulations of a drug used to treat tension headaches, the company said Monday.

July 29, 2013

U.S.-based drug maker Perrigo Co. will buy Ireland's Elan Corp. for $8.6 billion, the companies said.

July 29, 2013

Drug maker Pfizer is planning to split its commercial division into three business lines that will separate its branded and generic products, the company said Monday.

July 26, 2013

While rates of human papillomavirus infection among girls ages 14 years to 19 years have dropped by half since the Centers for Disease Control and Prevention started recommending routine vaccination against it seven years ago, rates of vaccination have not increased, the agency said.

July 26, 2013

A new track-and-trace bill that the Senate is expected to consider would institute a nationwide "track-and-trace" system in place of patchwork state laws with the aim of securing the pharmaceutical supply chain.

July 24, 2013

Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer.

July 23, 2013

A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial.

July 22, 2013

The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

July 22, 2013

A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

July 19, 2013

Boys whose mothers receive flu shots or Pap screenings are more likely to receive the human pappilomavirus vaccine, according to a new study.

July 19, 2013

A drug-safety website operated by drug maker Purdue Pharma has won accolades from an international awards program for marketing and communications.

July 19, 2013

Royalty Pharma has hired Marshall Urist as VP research and investments, the company said Friday.

July 18, 2013

Almost twice as many drugs for neglected diseases have received regulatory approval around the world over the past few years compared with the beginning of the last decade, according to a new study.

July 17, 2013

New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

July 16, 2013

Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.