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.

February 8, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

February 8, 2013

A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International.

February 6, 2013

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

February 6, 2013

The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

February 6, 2013

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

February 5, 2013

A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

February 4, 2013

The Food and Drug Administration has approved a generic version of a cancer drug in a move that the agency said would help relieve shortages.

February 4, 2013

Walgreens on Monday made available a new application programming interface that allows third-party mobile app developers to integrate the drug store chain’s prescription refill technology.

February 1, 2013

The Food and Drug Administration has approved a new drug for treating some disorders that harm the body's ability to remove ammonia from the blood, the agency said Friday.

January 28, 2013

The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.