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The Medicines Co. recalls 11 lots of Cleviprex (clevidipine butyrate) injectable emulsion due to the potential presence of visible...[ Price : $8.95]
FDA publishes an addendum to the ICH S6 guidance on safety evaluation of biotechnology-derived drugs.[ Price : $8.95]
FDA clears EnzySurges wound management product SilverStream.[ Price : $8.95]
Jazz Pharmaceuticals submits an NDA for JZP-6 (sodium oxybate oral solution), indicated for treating fibromyalgia.[ Price : $8.95]
Elan halts trials of an investigational Alzheimers drug at the two highest dose levels being studied.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Advanced Medical Optics, Craig Buettner, Endotec, Freeman Mfg, Huaiyin Medical I...[ Price : $8.95]
FDAs Florida District Office warns Endotec of numerous Quality System and corrective action reporting violations at its facility t...[ Price : $8.95]
An Illinois federal court rejects FDAs interpretation of the word affiliate in determining that it does not have to grant an NDA f...