Regulatory Affairs Syndicator

Street.Com - Novartis asked the Food and Drug Administration to vote in support of Prexige in 2002, but the agency wanted more clinical data. The Swiss drugmaker later withdrew the request to conduct more tests. Novartis now says it will refile its application …

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 …

Morris County Daily Record - The Food and Drug Administration allowed Celebrex to stay on the market because there wasn’t enough data linking it with a higher risk of cardiovascular side effects. Pfizer had Celebrex sales of $537 million in the third quarter of this year. The …

MSN MoneyCentral - CHBP announced today that all required clinical trials for both Torasemide tablets and Injections have been completed, and the Company is waiting for final manufacturing and marketing approval from the State Food and Drug Administration of China …

Fort Lauderdale Sun-Sentinel - 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 …

CNN Money - Food and Drug Administration. The brand products covered by these applications have annual U.S. sales of $87 billion. Global sales of Copaxone, Teva’s multiple sclerosis drug, rose 15 percent in the quarter to $354 million. The board declared a cash …

Phramalive.com - EXTON, Pa., November 07, 2006 /PRNewswire/ — Morphotek(R) Inc., a privately held biopharmaceutical company focused on the discovery and development of therapeutic monoclonal antibodies, announces that the United States Food and Drug Administration …

MSN MoneyCentral - … any disappointing news related to insomnia drug Indiplon would likely be offset by gains from other products. Neurocrine’s stock plunged on Friday after the company said it planned to conduct more studies on Indiplon. The Food and Drug Administration …

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 …

News Sun - The purchase came with Humira, a rheumatoid arthritis drug, that won marketing approval from the Food and Drug Administration in 2004. Humira is already a blockbuster with this year’s sales expected to reach beyond $1 billion. Abbott, no doubt, hopes …

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 …

Houston Business Journal - Food and Drug Administration in an approvable letter that it had an outstanding item related to a separate letter issued in March. It expects to hear by Dec. 2 whether the response it submitted to the FDA last week will be accepted. Encysive is …

Daily Local News - UWCHLAN — In the latest in a series of setbacks for its flagship drug Entereg, Adolor Corp. learned early Monday that the Food and Drug Administration wants more safety data on its drug to combat post-operative bowel problems. Adolor is developing …

Austin American-Statesman - Introgen is awaiting a Food and Drug Administration decision on its leading product, Advexin, a drug designed to treat head and neck cancers. The company didn’t hold a conference call after its earnings report, saying it would discuss …

Reuters - Food and Drug Administration (FDA) expected to approve Entereg as a treatment to help patients recover from bowel surgery. However, the FDA wants to see 12-month safety data from an ongoing clinical trial of Entereg as a treatment of opiate-induced …