December 12, 2013

A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.

December 11, 2013

The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said.

December 10, 2013

NEW YORK — Absorption Pharmaceuticals will be conducting clinical trials with Kaiser to measure the efficacy of the company's over-the-counter solution for PE Promescent, CNBC reported Tuesday.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

December 5, 2013

Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.

December 4, 2013

The Food and Drug Administration has approved a new topical drug for treating scars made by Oculus Innovative Sciences, the drug maker said Wednesday.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

December 2, 2013

The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

November 26, 2013

The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

November 25, 2013

The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

November 21, 2013

The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

November 15, 2013

The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

November 15, 2013

The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.

November 15, 2013

The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

November 13, 2013

The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

November 11, 2013

The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets.

November 8, 2013

Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 5, 2013

The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

November 5, 2013

A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

November 4, 2013

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.