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Dexcom Glucose Monitor Approved by FDA

[ Price : $8.95]

FDA approves Dexcoms continuous glucose monitoring system, the Dexcom G4 PLATINUM.

PolyMedix Receives FDA Guidance on Brilacidin

[ Price : $8.95]

PolyMedix receives guidance in a meeting with FDA on a Phase 2B protocol for its brilacidin in treating acute bacterial skin and s...

Info on Safety Labeling Changes Guidance Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on a draft guidance on safety labeling changes to the Of...

Public Hearing on Potentially Threatening Pathogens

[ Price : $8.95]

Federal Register Notice; FDA plans a public hearing 12/18 to gain input on establishing a list of qualifying pathogens that have t...

FDA Inspection of Janssen Biotech Cites Remicade Manufacturing

[ Price : $8.95]

FDA cites Janssen Biotechs Malvern, PA facility for failing to adequately investigate unexplained discrepancies related to Remicad...

Cumberland Pharma Sues FDA Over Generic Acetadote

[ Price : $8.95]

Cumberland Pharmaceuticals files a lawsuit against FDA challenging the agencys decision to deny a citizen petition and approve Inn...

FDA Clears Quantel Ophthalmic Laser

[ Price : $8.95]

FDA clears a Quantel Medical 510(k) for its SupraScan 577 Laser, an ophthalmic laser system for treating a wide range of retinal d...

Panel to Discuss CoAxia NeuroFlo Catheter Device

[ Price : $8.95]

Federal Register Notice: FDAs Neurological Devices Panel will meet 12/10 to discuss the safety and effecitiveness of the CoAxia Ne...

Balance Transparency with Personal, Commercial Privacy: EFPIA

[ Price : $8.95]

The European Federation of Pharmaceutical Industries and Associations says steps must be taken to balance transparency with person...

Company Wants Supreme Court Decision in Sulindac Warning Case

[ Price : $8.95]

Mutual Pharmaceutical says the Supreme Court should resolve a split among appeals courts on whether its failure-to-warn preemption...