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FDA Accepts NDA from Aprecia Pharma Using Novel Delivery Formulation

[ Price : $8.95]

FDA accepts for filing an Aprecia Pharmaceuticals NDA for the first product using its proprietary ZipDose technology.

QS Problems Found in US Infusion Inspection

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FDAs Florida District Office warns US Infusion, Inc., about multiple Quality System Regulation violations in its work as a specifi...

AstraZeneca Prevails in Nexium Pay-for-Delay Lawsuit

[ Price : $8.95]

A Boston federal jury finds that a reverse payment or so-called pay-for-delay agreement between AstraZeneca and Ranbaxy Laboratori...

Think Surgical Robotic Surgical System Cleared by FDA

[ Price : $8.95]

Think Surgical gains 510(k) clearance for its new TSolution On Surgical System for total hip arthroplasty.

FDA Draft Guidance on Drug Distributor Annual Reporting

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FDA releases a draft guidance on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Di...

FDA Clears Advaxis IND for Prostate Cancer Combo Therapy

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FDA clears an Advaxis IND application to conduct a Phase 1/2 clinical study to evaluate the combination of ADXS-PSA with Mercks Ke...

OtisMed, Ex-CEO Plead Guilty Over Unapproved Device

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OtisMed Corp. and its former chief executive officer enter guilty pleas to intentionally distributing knee replacement surgery cut...

FDA Draft Guidance on Pediatric Clin-Pharm Considerations

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FDA posts a draft guidance on General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products...

FDA Approves New Indication for Amgens Xgeva

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FDA approves an Amgen supplemental BLA for a new indication for Xgeva (denosumab) treating hypercalcemia of malignancy that is re...

EMA Probes Data Integrity Issues at Indian CRO

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Several European Union member states suspend the marketing authorizations of medicines that have been authorized on the basis of s...