Regulatory Affairs Syndicator

Reuters Health News SummarySan Diego Union Tribune, United States - Feb 23, 2008Genentech shares jumped nearly 9 percent in extended trading as most industry watchers had expected the Food and Drug Administration either to delay a …

Malaysia StarWhat’s your flavour?Malaysia Star, Malaysia - 6 hours ago1995: The Food and Drug Administration (USA) asked the Federation of the American Society for Experimental Biology (FASEB) to conduct another review of MSG. …

Abbott's Humira wins OK to treat juvenile arthritisChicago Tribune, United States - 6 hours agoThis is the sixth use for Humira approved by the Food and Drug Administration and the second this year, the North Chicago -based company said….

Wall Street JournalGenentech drug, chemo combo approved Silicon Valley / San Jose …Bizjournals.com, NC - 1 hour agoGenentech Inc. said Friday the Food and Drug Administration granted accelerated approval for its drug Avastin in combination …

Last Call: Eli LillyForbes, NY - Feb 22, 2008… a Lehman Brothers analyst predicted Friday, after the drug maker received priority review from the Food and Drug Administration. …Drug stocks decline; Dynavax, Endo, ImClone climb MarketWatch…

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

Final Guidance. This guidance is intended for all fresh-cut produce firms, both domestic and foreign, to enhance the safety of fresh-cutproduce by minimizing the microbial food safety hazards. This guidance is not a set of binding requirements nor does it identify all possible preventive measures to minimize microbial food safety hazards.

Given Imaging Receives NSE Letter From the US Food and Drug …PR-USA.net (press release), Bulgaria - Feb 22, 2008Given Imaging Ltd. ( NASDAQ : GIVN), the global leader in capsule endoscopy, today announced that the US Food and Drug Administr…

The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.

Dog Flu Diet and DiseasesMedical device makers get a passTheNewsTribune.com, WA - 49 minutes ago… the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court rule…

Food and Drug Administration snubbed offer by USDA to help inspect …GovExec.com, DC - 6 hours agoBy Anna Edney CongressDaily February 19, 2008 The Agriculture Department's Food Safety and Inspection Service has tried to persuade FDA to …

Shares of Given Imaging slump on FDA's NSE letter for PillCam ColonCNNMoney.com - 2 hours ago… slumped Tuesday after the company received a not substantially equivalent (NSE) letter from the Food and Drug Administration regarding its applic…

Marshall Edwards: Triphendiol gets additional orphan drug statusReuters - 1 hour agoO: Quote, Profile, Research) said its experimental cancer drug triphendiol was granted an orphan drug status by the US Food and Drug Administration for …

Amarillo Bioscience Partner, CytoPharm, to Conduct 144 Patient …CNNMoney.com - 3 hours agoAmarillo Biosciences, Inc.(OTCBB: AMAR) today announced that the US Food and Drug Administration has allowed the Investigational New Drug (IND) application…

Solvay's Duodopa intestinal gel gets FDA fast track status for …Forbes, NY - 1 hour agoBRUSSELS (Thomson Financial) - Solvay SA said the US Food and Drug Administration has granted fast track designation for Duodopa, the levodopa/carbi…