December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

November 28, 2011

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

November 10, 2011

The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

November 2, 2011

The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

October 28, 2011

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 27, 2011

A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

October 25, 2011

Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

October 20, 2011

Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

September 28, 2011

Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

September 1, 2011

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

August 29, 2011

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

August 23, 2011

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

August 12, 2011

Lannett announced that it has started shipping morphine sulfate oral solution, a painkiller approved by the Food and Drug Administration in June.

August 4, 2011

GlaxoSmithKline company Stiefel announced it is seeking approval for a facial acne treatment in patients ages 12 years and older.

August 1, 2011

The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

July 26, 2011

Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

July 18, 2011

Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

June 27, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.