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ZymoGenetics says that FDA should revoke King Pharmaceuticals BLA for Thrombin-JMI because its risks outweigh its benefits.[ Price : $8.95]
Sandoz asks FDA to require Teva and Alpharma to submit Paragraph 4 certifications as part of their ANDAs for generic Actos.[ Price : $8.95]
Consulting editor John Scharmann reviews various misadventures in governmental transparency and concludes that until both the exec...[ Price : $8.95]
FDA says there have been complaints of inaccurate readings with four specific Philips Avalon fetal monitors.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites ANIP Acquisition Co., Biomed Devices, Cambrex Profarmaco Milano, Cooley Dickinso...[ Price : $8.95]
Novartis revises Myfortics labeling to warn of a potential for patients developing pure red cell aplasia with its use.[ Price : $8.95]
FDA says an advisory committee will be asked to review the abuse potential of Acura and Kings oxycodone/niacin drug Acurox.[ Price : $8.95]
FDA swiftly rebuts criticism that it hid for two years the danger of lead in lipstick, revising its Web site saying there is no da...