Topic: Food and Drug Administration
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 ...
Watson Pharmaceuticals Inc. said the Food and Drug Administration approved a six-month dose of the prostate cancer drug Trelstar, which already was available in one- and three-month doses. Trelstar is developed by Debiopharm Group of Switzerland and marketed by Watson. Watson plans to launch the six-month dose in ...
