April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 21, 2011

The Food and Drug Administration has approved a diabetes drug made by Lupin Pharmaceuticals, according to published reports.

April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

April 20, 2011

The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

April 20, 2011

Johnson & Johnson on Tuesday announced that distribution of McNeil Consumer Healthcare consumer products will slow in the coming months as the company shifts production of its over-the-counter medicines to other manufacturing plants and implements additional third-party quality controls within those plants.

April 20, 2011

The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

April 19, 2011

The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

April 19, 2011

The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.

April 18, 2011

The Food and Drug Administration has approved a drug made by Genentech for treating a rare and severe form of arthritis that affects children, Genentech said.

April 18, 2011

A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

April 18, 2011

The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

April 18, 2011

The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

April 15, 2011

Abbott Diagnostics on Friday announced its filing of a submission for clearance by the Food and Drug Administration for a fully automated vitamin D assay performed on its Architect testing system for use by healthcare professionals.

April 15, 2011

Takeda Pharmaceutical has launched a new treatment for high blood pressure, the company said Friday.

April 14, 2011

The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

April 14, 2011

The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

April 13, 2011

The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.

April 13, 2011

A Food and Drug Administration expert panel has given a favorable vote to a drug made by Pfizer for tumors, Pfizer said Tuesday.

April 12, 2011

Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

April 12, 2011

The Food and Drug Administration has approved a treatment made by Merck for treating skin cancer, Merck said Monday.

April 11, 2011

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

April 11, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

April 11, 2011

The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

April 8, 2011

The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.