News Topic - FDA

J&J Schizophrenia Drug Faces FDA Delay
The regulator asked for additional data on paliperidone palmitate, an investigational once-monthly intramuscular injection for schizophrenia.
TheStreet.com  –  Aug 26, 2008 9:19 PM [GMT]  ¦  comment?
found in Business: Investing

FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia
Read full story for latest details.
PR Newswire  –  Aug 26, 2008 8:37 PM [GMT]  ¦  comment?
found in Top Stories: Press Releases

Biogen, Elan Drug Gets New FDA Warning
Multiple sclerosis treatment Tysabri may cause a deadly brain infection whether used alone or with other treatments.
TheStreet.com  –  Aug 26, 2008 7:21 PM [GMT]  ¦  comment?
found in Business: Investing

FDA Considering Food Allergy Labels
That’s because for people with food allergies, finding out if your food is dangerous can be tough.
WSPA - News Channel 7  –  Aug 26, 2008 6:03 PM [GMT]  ¦  comment?
found in Local: South Carolina: Greenville

FDA Allows Irradiation of Your Vegetables
The FDA has approved irradiation of spinach and iceberg lettuce to kill food-borne pathogens, a Band-Aid approach to food safety that may ultimately hurt small, local farmers.
LiveScience.com  –  Aug 26, 2008 5:30 PM [GMT]  ¦  comment?
found in Technology: Science

Biogen, Elan lead drug stocks higher
BOSTON (MarketWatch) -- Drug stocks moved higher in early trading Tuesday as shares of partners Elan Corp. and Biogen Idec rose moderately the day after U.S. regulators said they were updating the labeling of their drug Tysabri to reflect renewed safety concerns. The Amex Pharmaceutical Index was up nominally at 309.9 and the Amex Biotechnology Index advanced 0.4% to 844.1. Biogen shares edged up 1% to $54.02, while Elan shares hopped 4% to $14.81. Late Monday, the Food and Drug Administration advised doctors that although two new cases of the rare brain disease PML have been discovered amongst Tysabri users, the agency still believes the drug can be used relatively safely with close monitoring. The FDA added it was updating Tysabri's label to reflect the two new PML cases.Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
MarketWatch.com  –  Aug 26, 2008 2:00 PM [GMT]  ¦  comment?
found in Business: Markets

New FDA Produce Irradiation Rule
The Food and Drug Administration's new (Aug. 22) regulation that will allow irradiation pasteurization to be used on fresh spinach and iceberg lettuce to kill illness-causing bacteria is a step that two Iowa State University professors have long advocated. Dennis Olson is a professor of animal science and directs Iowa State's Linear Accelerator Facility, one of only two commercial-sized irradiation facilities for food research and demonstration on a U.S. university campus.
Medical News Today  –  Aug 26, 2008 08:00 AM [GMT]  ¦  comment?
found in Health: Fitness and Nutrition

Biogen, FDA Work to Alter Tysabri Label
Biogen and Elan are working with the FDA to amend the label for the multiple-sclerosis drug Tysabri after two patients in Europe got a serious brain disorder while taking it.
Wall Street Journal  –  Aug 26, 2008 01:07 AM [GMT]  ¦  comment?
found in Politics

FDA may set rules for food allergy warnings
It's one of the biggest frustrations of life with food allergies: That hodgepodge of warnings that a food might accidentally contain the wrong ingredient.
CNN.com  –  Aug 25, 2008 10:24 PM [GMT]  ¦  comment?
found in Health

FDA wants Biogen, Elan drug warning revised
Reuters - Prescribing instructions for Biogen Idec and Elan Corp's drug Tysabri should be revised to note cases of a serious brain disorder in patients who were using it as their sole treatment for multiple sclerosis, U.S. health regulators said on Monday.
Yahoo!  –  Aug 25, 2008 7:44 PM [GMT]  ¦  comment?
found in Technology: Science