Regulatory Affairs Syndicator

Forbes - The company said it has a new drug for treating obesity in phase 3 testing that could compete with Sanofi-Aventis ‘ (nyse: SNY - news - people ) rimonabant compound now under review by the Food and Drug Administration. Meanwhile …

Chicago Tribune - Food and Drug Administration told Pfizer earlier this year it needed more information on Zeven before approval. Pfizer acquired Zeven along with a product already on the market for treating hospital-acquired blood infections called Eraxis when it …

Reuters - Food and Drug Administration in 2007. “Arpida aims to launch iclaprim in its first indication in the U.S. in 2008. The oral formulation is between one year and one and a half years behind the intravenous formulation,” a spokesman for the company said. …

MSNBC - Food and Drug Administration approved it in 2000 for medical abortions in women pregnant as long as seven weeks. Part of abortion-inducing combo Mifeprex blocks production of progesterone, which keeps a fertilized egg implanted in the uterus. Mifeprex …

MSN MoneyCentral - Catalyst, based in Coral Gables, Fla., was granted fast-track status by the Food and Drug Administration for a cocaine addiction treatment that is in clinical trials. But it has not received FDA approvals for any of its drug candidates, and has never …

MSN MoneyCentral - Protect has been given fast-track status by the Food and Drug Administration, allowing the company to submit data in an ongoing basis. Prostate cancer is the most common non-skin cancer in the United States and the third most common worldwide. “The …

Newsday - … to treat macular degeneration, a major cause of vision loss in people older than 60, is facing strong competition from Lucentis, a macular degeneration drug made by Genentech and given approval earlier this year by the Food and Drug Administration. …

My West Texas - The Associated Press reports that artificial trans fat is so common that the average American eats 4.7 pounds of it a year, according to the Food and Drug Administration. Artificial trans fat is considered to be so unhealthy that health officials say …

Philadelphia Business Journal - CEPH) received an approvable letter from Food and Drug Administration for Nuvigil in May. Approvable letters are issued when the FDA wants more information about a drug it believes can be approved. A final decision on the application is expected by …

Phoenix Business Journal - Medicis Pharmaceutical Corp. and Dow Pharmaceutical Sciences Inc. Tuesday announced that the U.S. Food and Drug Administration approved its Ziana Gel for the treatment of acne in patients 12 years and older. Ziana Gel is the only combination of …

MSN MoneyCentral - In October, the company filed a marketing application with the Food and Drug Administration for the drug, which will be called Junovan in the U.S. market. © 2006 The Associated Press. All rights reserved. This material may not be published, broadcast …

Newsday - Risperdal, an anti-psychotic drug, has just been approved by the Food and Drug Administration to treat the symptoms of autism in children and adolescents ages 5 to 16. It’s the first time the FDA has approved any drug to treat behaviors such as …

MSN MoneyCentral - CEPH) received an approvable letter from Food and Drug Administration for Nuvigil in May. Approvable letters are issued when the FDA wants more information about a drug it believes can be approved. A final decision on the application is expected by …

MSN MoneyCentral - On Sept. 28, 2005, the company disclosed the Food and Drug Administration determination the agency was not likely to approve Noven’s generic version of Duragesic, a pain patch. Helped by the lack of an inventory write-off in the most recent period …

Phramalive.com - NORWALK, Conn.–(BUSINESS WIRE)–Nov 7, 2006 - The next Congress will have a major impact on the U.S. Food and Drug Administration and the pharmaceuticals industry as a whole. The RPM Report, a Windhover publication, is providing two timely forums to …