PLAVIX PROBLEM: The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blockbuster blood thinner. GENETIC CAUSE: A small percentage of people have a genetic variation that prevents them from making an enzyme needed ...

Drugmaker Eisai Inc. said the Food and Drug Administration approved a new, longer dosing regimen of its bone marrow disease treatment Dacogen. Eisai said the FDA cleared a five-day regimen of Dacogen as a treatment for myelodysplastic syndrome. The drug, which was developed through a partnership ...

Big Tobacco suffered a big loss as Vermont Superior Court Judge Dennis Pearson found that R.J. Reynolds Tobacco Company’s advertising claims of a “reduced risk” cigarette were deceptive and misleading, in violation of Vermont’s Consumer Fraud Act and a 1998 settlement agreement and court order. “This is a huge decision ...

(Reuters) - Diagnostics products maker Neoprobe Corp said U.S. health regulators have indicated that data from a late-stage trial of its radioactive tracing agent would support filing for marketing approval. The company recently met the U.S. Food and Drug Administration to review the late-stage trial results of its experimental radioactive tracing agent, Lymphoseek, which seeks to determine the spread ...