December 23, 2013

The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

December 23, 2013

The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

December 23, 2013

The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

December 19, 2013

Diplomat has become a distributor of a new cancer drug made by Genentech, Diplomat said Thursday.

December 18, 2013

Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

December 18, 2013

The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

December 18, 2013

The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

December 16, 2013

Endo Health Solutions will acquire the maker of a patch used to treat migraines that received Food and Drug Administration approval at the beginning of this year.

December 16, 2013

The Food and Drug Administration may require makers of antibacterial soaps to perform clinical trials to show their products are better at preventing infections and disease than ordinary soaps.

December 13, 2013

Pharmacy benefit manager Express Scripts hopes to drive down the cost of new drugs to treat hepatitis C by pitting their manufacturers against each other, according to published reports.

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 12, 2013

GlaxoSmithKline announced that a peer-reviewed study issued online by the New England Journal of Medicine has reported that GSK’s FluLaval Quadrivalent reduced flu cases among children ages 3 years to 8 years by 55.4% overall and lowered the risk of developing moderate-to-serious flu illness by 73.1%.

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 11, 2013

The Food and Drug Administration is planning to limit the use of antimicrobials in food animals in an effort to stem the rise of antibiotic-resistant bacteria, the agency said Wednesday.

December 11, 2013

A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

December 10, 2013

An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

December 9, 2013

Swiss drug maker Novartis is providing a vaccine to Princeton University amid an outbreak of potentially fatal meningitis that has affected at least eight students, the university said Monday.

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 6, 2013

The Food and Drug Administration has approved a treatment for a sexual deformity that affects men.

December 6, 2013

The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.

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 4, 2013

The Food and Drug Administration issued a safety communication on HeartStart automated external defibrillators from Philips Healthcare.

December 3, 2013

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