FDA NEWS

GlaxoSmithKline says FDA approves KINRIX combination vaccine for - CNBC
PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have
Source: www.cnbc.com

FDA OKs GlaxoSmithKline kids' combination vaccine - CNBC
PHILADELPHIA - GlaxoSmithKline PLC said Wednesday it won Food and Drug Administration approval for a combination vaccine to protect children against diphtheria, tetanus, pertussis and polio. Glaxo said the vaccine, Kinrix, is the first to combine
Source: www.cnbc.com

Salmonella outbreak illnesses rise to 756 - Reuters
WASHINGTON (Reuters) - More than 750 people have become ill in an outbreak of Salmonella linked to certain types of tomatoes, U.S food safety officials said on Thursday. The U.S. Centers for Disease Control and Prevention said 756 people in 34 states
Source: www.reuters.com

Merck Gets Dealt FDA Setback On Gardasil Marketing - CNN Money
Merck & Co. (MRK) ran into a rare roadblock for its blockbuster cervical- cancer vaccine Gardasil when the Food and Drug Administration put off a decision on allowing sales to older women. The FDA denied the pharmaceutical giant's supplemental
Source: money.cnn.com

FDA won't clear expanded Merck cancer vaccine use - Reuters
NEW YORK (Reuters) - U.S. regulators did not approve Merck & Co's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women within an expected review period, the drugmaker said on Wednesday. Merck had applied
Source: www.reuters.com

GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes
PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have
Source: www.forbes.com

Committee critical of FDA bonuses - Seattle Post Intelligencer
WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday
Source: seattlepi.nwsource.com

FDA blocks expanded indication for Merck's Gardasil - Boston Globe
WHITEHOUSE STATION, N.J.— Merck & Co. said Wednesday the Food and Drug Administration rejected expanding the use of cervical cancer vaccine Gardasil to include women ages 27 to 45, citing "issues that preclude approval" within the expected review
Source: www.boston.com

The FDA's Latest Victim - Motley Fool
The FDA just can't seem to approve anything these days. Earlier in the week, the agency delayed Eli Lilly 's (NYSE: LLY ) heart drug, prasugrel. Now, Merck (NYSE: MRK ) says it'll have to wait for a label change to its already-approved human
Source: www.fool.com