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Plavix Doesnt Mix Well With PPIs

[ Price : $8.95]

Medco Health Solutions researchers say that taking a proton pump inhibitor along with Plavix may interfere with Plavix anti-platel...

Pixantrone Rolling NDA Planned

[ Price : $8.95]

Cell Therapeutics will start a rolling NDA in 2009 for its pixantrone.

FDA Approves Trial of Celgene Stem Cell Therapy

[ Price : $8.95]

FDA says Celgene Cellular Therapeutics may conduct a Phase 1 trial of its investigation immunomodulatory therapy using human place...

J&J-Merck Recall Infant Mylicon Drops

[ Price : $8.95]

Johnson & Johnson-Merck Consumer Pharmaceuticals Company recalls about 12,000 units of Infants' Mylicon Gas Relief Dye-free Drops.

FDA Clears CNSystems Continuous BP Monitor

[ Price : $8.95]

FDA clears a CNSystems Medizintechnik 510(k) for the CNAP Monitor 500, intended for measuring continuous blood pressure in real-ti...

FDA: No Long-term Studies on Remoxys Tamper Resistance

[ Price : $8.95]

FDA reviewers say Pain Therapeutics did not conduct long-term studies to determine whether its proposed abuse-resistant formulatio...

Obama Could Increase Off-label Enforcement

[ Price : $8.95]

Attorney and ex-FDAer Marc Scheineson says drug companies fear that the incoming Obama administration may step up enforcement of o...

Branded Company May Be Liable for Generic Adverse Events

[ Price : $8.95]

A California appeals court says a failure-to-warn suit brought against Wyeth by someone claiming injuries from a generic form of a...

Von Eschenbach Defends Preemption

[ Price : $8.95]

Skirting the nub of the preemption issue now pending in the Supreme Court, FDA commissioner Andrew von Eschenbach says FDA must ha...

GSK to Resubmit Solzira NDA

[ Price : $8.95]

GlaxoSmithKline says it has withdrawn its Solzira NDA and will resubmit it with trial data reformatted as requested by FDA.