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FDA Lifts Clinical Hold on Pancreatic Cancer Therapy

[ Price : $8.95]

FDA lifts a partial clinical hold against an Immunomedics clinical study involving clivatuzumab tetraxetan in patients with advanc...

FDA Approves TriVascular Abdominal Stent System

[ Price : $8.95]

FDA approves the TriVascular Ovation abdominal stent system as a Humanitarian Use Device.

Edwards Sapien Heart Valve Approved

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FDA approves an Edwards Life Sciences PMA for the Sapien Transcatheter Heart Valve, the first such device that can replace an aort...

Endo Pharma Generic Plendil Approved

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FDA approved an Endo Pharmaceuticals ANDA for a generic copy of Plendil extended-release tablets.

Revised Guidance on Residual Solvents in New Animal Drugs

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Federal Register Notice: FDA releases a revised ICH guidance on acceptable amounts of residual solvents in new animal drugs.

FDA Issues Q&A on 3 IHC Guidances

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FDA issues a question and answer guidance to clarify issues that arisen in implementation of three ICH drug guidances.

Study Finds No ADHD Drug/Cardiovascular Event Association

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FDA says results of a large study show no association between use of ADHD drugs in children and young people and an increased risk...

QS Violations Found at Cagenix

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FDAs New Orleans District Office warns Cagenix about Quality System violations in its manufacturing of dental bridge frameworks.

Exelixis Starting Prostate Cancer Phase 3 Cabozantinib Trial

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Exelixis says it will start a Phase 3 trial of cabozantinib for treating castration-resistant prostate cancer.

State Law Backing FDA Preemption Hurts Consumers, Industry

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Michigan resident Henry Greenspan urges Wisconsin not to approve a law preventing consumer state tort suits alleging that FDA-appr...