March 11, 2013

Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

March 8, 2013

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

March 5, 2013

Generic drug maker Dr. Reddy's Labs has launched a drug used to treat certain cancers, the company said Tuesday.

March 5, 2013

The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

March 4, 2013

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

March 4, 2013

The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.

March 1, 2013

The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

February 28, 2013

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.

February 26, 2013

The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

February 26, 2013

Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

February 25, 2013

The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

February 22, 2013

The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

February 21, 2013

The Food and Drug Administration has approved a new vial size for a drug made by CSL Behring to treat a bleeding disorder and an immune disorder, the company said.

February 19, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

February 19, 2013

The Food and Drug Administration has granted priority review to an experimental drug made by ViiV Healthcare for HIV, the company, a joint venture between British drug maker GlaxoSmithKline and American drug maker Pfizer, announced.

February 19, 2013

The Food and Drug Administration and the Federal Trade Commission issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA.

February 15, 2013

U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla.

February 14, 2013

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

February 13, 2013

The Food and Drug Administration has given a special, new designation to a cancer drug under development by Johnson & Johnson and Pharmacyclics, the companies said.

February 12, 2013

Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

February 12, 2013

Putney has launched a generic version of a veterinary skin infection drug, the company said.

February 12, 2013

GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

February 8, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.