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FDA Clears New Roche cobas Diagnostic Platform

[ Price : $8.95]

Roche gains FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform.

ClearPoint Neuro Navigation Software Cleared

[ Price : $8.95]

FDA clears a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software.

Vanda Agrees to Pay Over $11 Million in Off-label Suit

[ Price : $8.95]

Vanda Pharmaceuticals agrees to settle an off-label marketing case for $11.5 million.

Researcher Convicted in FDA False Statement Case

[ Price : $8.95]

A federal jury convicts former clinical researcher for making a false statement to a government investigator related to her role i...

DoJ Renews Individual Accountability Interest in Prosecutions

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The Department of Justice says its top priority for corporate criminal enforcement is individual accountability by targeting the i...

Pfizer Plans BLA for New Meningococcal Vaccine

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Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY).

FDA Panel to Discuss Kidney Disease Drug

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Federal Register notice: FDA announces an 11/16 advisory committee meeting to discuss an Ardelyx NDA for tenapanor hydrochloride t...

Heron Gets NDA Approved for Aponvie

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FDA approves a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea ...

ICH Guide on Elemental Impurities

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Federal Register notice: FDA releases a final guidance entitled Q3D(R2) Guideline for Elemental Impurities.

FDA Reminds on Endotracheal Tube Obstructions

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CDRH updates a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of ...