November 8, 2013

The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.

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 8, 2013

A proposed rule from the Food and Drug Administration would effectively eliminate artificial trans fats from foods in the United States by classifying partially hydrogenated oils as unsafe food additives and thus permitting them only in certain cases.

In its proposal, the FDA emphasized that it would give manufacturers of foods that contain trans fats enough time to reformulate their recipes in order to minimize market disruptions by spreading out the initial cost of about $8 billion over a number of years. While trans fats have been eliminated from most foods already, foods that still contain them include frozen pizzas, microwave popcorn, margarines and some dessert foods.

November 7, 2013

U.S. regulators made a preliminary move Thursday to remove trans fats from food products.

November 6, 2013

Noven Pharmaceuticals has launched a new drug for severe hot flashes nationwide, the company said.

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 4, 2013

Silvergate Pharmaceuticals has launched a new drug for treating high blood pressure in children, the company said Monday.

November 4, 2013

The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

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.

November 4, 2013

Drug maker UCB is seeking approval for one of its drugs as a standalone therapy for epilepsy.

November 1, 2013

Indian drug maker Dr. Reddy's Labs had sales of $536 million in second quarter 2014 and profits of $110 million, the company said.

November 1, 2013

The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

November 1, 2013

The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

November 1, 2013

Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

November 1, 2013

The Food and Drug Administration has released a new video that warns consumers against buying drugs from rogue-internet pharmacies, part of the ongoing effort by the agency to keep fake and contaminated drugs out of the U.S. supply chain.

October 31, 2013

Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

October 31, 2013

The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

October 31, 2013

Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

October 31, 2013

Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze gel.

October 30, 2013

Tria Beauty, a maker of light-based skin care, has received FDA clearance for the company's Age-Defying Laser, the company has announced.

October 29, 2013

Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.

October 29, 2013

In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

October 29, 2013

The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.