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.

October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

October 28, 2013

The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

October 25, 2013

A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

October 25, 2013

The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

October 25, 2013

The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

October 25, 2013

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

The desire to combat abuse and misuse of prescription drugs — now a worse problem in the United States than cocaine or heroin — is laudable, but unlike those two drugs, hydrocodone has a legitimate use as a painkiller, and it's the people who are using it properly and legally who will end up losing.

October 24, 2013

An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

October 24, 2013

The Food and Drug Administration has approved a new formulation of a drug made by Genentech for rheumatoid arthritis that can be injected into the skin.

October 24, 2013

The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.