April 30, 2013

The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

April 30, 2013

The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

April 30, 2013

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 29, 2013

A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

April 25, 2013

Actavis can launch a generic version of an attention deficit hyperactivity disorder drug made by Shire next year under an agreement between the two companies announced Thursday.

April 24, 2013

Generic drug maker Hospira marked its fifth year marketing knock-off versions of biotech drugs in Europe Wednesday as it presented at the 2013 Biotechnology Industry Organization International Convention this week.

April 23, 2013

The Food and Drug Administration has approved a second product in BD's new line of injectable drugs, the company said Tuesday.

April 23, 2013

The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

April 22, 2013

The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

April 16, 2013

The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

April 16, 2013

Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

April 16, 2013

Two Dallas-based compounding pharmacies announced a recall of sterile drug products made at their facilities due to production conditions that could lead to contamination.

April 15, 2013

Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.

April 12, 2013

The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

April 12, 2013

The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

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.