April 8, 2013

An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients' conditions, according to results of a late-stage clinical trial.

April 5, 2013

The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued by Judge Edward Korman of the U.S. District Court, Eastern District of New York.

April 4, 2013

The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection, the drug maker said.

April 4, 2013

A committee of Florida's state Senate has passed a bill that could limit the use of biosimilars in the state.

March 29, 2013

The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

March 29, 2013

The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

March 27, 2013

The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

March 27, 2013

The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said.

March 25, 2013

The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

March 22, 2013

A drug made by Novo Nordisk for Type 2 diabetes produced a 6% loss of weight in a trial of the drug in obese patients, the company said.

March 21, 2013

The Food and Drug Administration advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients.

March 21, 2013

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

March 21, 2013

Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

March 20, 2013

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

March 19, 2013

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

March 19, 2013

The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

March 19, 2013

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

March 18, 2013

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

March 14, 2013

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

March 14, 2013

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

March 14, 2013

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

March 14, 2013

SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

March 12, 2013

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 11, 2013

Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.