FDA NEWS

Ore Pharmaceuticals Files Investigational New Drug Application with - Genetic Engineering News
Ore Pharmaceuticals Inc. ( NASDAQ:ORXE ) announced today that it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for GL1001, the first clinical-stage inhibitor of the ACE2 enzyme. This orally
Source: www.genengnews.com

FDA Grants Conditional Approval to Interventional Spine's PercuDyn(TM - Genetic Engineering News
Interventional Spine, Inc. announced today that the U.S. Food and Drug Administration has approved the Company's investigational device exemption (IDE) application for its PercuDyn System for the treatment of degenerative disc disease (DDD). This
Source: www.genengnews.com

Industry Attacks FDA Over Salmonella Tomatoes Investigation - dbtechno.com
Washington (dbTechno) - The National Restaurant Association, the main trade group in the restaurant industry, has come out and asked Congress to investigate the U.S. Food and Drug Administration (FDA). This comes as the FDA has not been able to
Source: www.dbtechno.com

Aethlon Medical Announces Second HIV/AIDS Treatment Site - MSN MoneyCentral
Aethlon Medical is the developer of the Hemopurifier ® , a first-in-class medical device designed to treat infectious disease. The Hemopurifier ® provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and
Source: news.moneycentral.msn.com

Introgen seeks FDA approval for 'groundbreaking' cancer drug - Austin American-Statesman
An Austin biotechnology company on Monday became the first to apply for U.S. Food and Drug Administration approval of a gene therapy drug to treat recurring head and neck cancers. But it could be early 2009, at best, before Introgen Therapeutics Inc
Source: www.statesman.com

Tomato growers fault FDA for losses - Herald Tribune
Published Tuesday, July 1, 2008 at 4:30 a.m. Last updated Tuesday, July 1, 2008 at 4:25 a.m. To Palmetto tomato grower Bob Spencer, the U.S. Food and Drug Administration is starting to feel a lot like the Federal Emergency Management Agency. "What
Source: www.heraldtribune.com

FDA: Is the Tomato to Blame for Salmonella Outbreak? Is It Not? - Eflux Media
Three weeks after the Food and Drug Administration first warned consumers to avoid certain types of tomatoes for fear they would carry an uncommon type of Salmonella, known as Saintpaul, the number of people getting infected is rising with each day
Source: www.efluxmedia.com

GlaxoSmithKline responds to FDA’s Cervarix query - Philadelphia Inquirer
NEW YORK - GlaxoSmithKline PLC said today that it has responded to questions raised by the Food and Drug Administration over the cervical cancer vaccine Cervarix and will provide the agency with more complete late-stage study data in 2009. In
Source: www.philly.com

Ahead of the Bell: FDA reconsiders diabetes drugs - MSN MoneyCentral
WASHINGTON (AP) - Government regulators are reconsidering how they approve diabetes drugs. They were criticized last year for their handling of heart risks connected with a widely used GlaxoSmithKline pill. The Food and Drug Administration will hear
Source: moneycentral.msn.com