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Centurion Class 1 Recall of Catheters

[ Price : $8.95]

Centurion begins a Class 1 recall of its Multi-Med Single Lumen Catheters due to excess material at the tip that may split or sepa...

FDA Officials Leery About Real World Evidence Potential

[ Price : $8.95]

FDA officials examine real world evidence and its potential to contribute efficiently to current knowledge gained from traditional...

FDA Guide on Identifying Suspect Drug Supply

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Federal Register Notice: FDA makes available a guidance on Drug Supply Chain Security Act Implementation: Identification of Suspec...

Ex-Pharma Execs Arrested in Racketeering Scheme

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Feds arrest several former pharmaceutical executives and managers at Insys Therapeutics on charges that they led a nationwide cons...

ProNova Gains FDA Clearance for Proton Therapy

[ Price : $8.95]

ProNova Solutions receives FDA 510(k) clearance for its SC360 proton therapy system, a compact 360-degree pencil beam scanning pro...

Docket Opened for Drug Review Assessment Under PDUFA

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Federal Register Notice: FDA creates a docket to obtain comments on the final assessment of the Program for Enhanced Review Transp...

FDA Denies Petition Seeking Optimal Naloxone Dose

[ Price : $8.95]

FDA denies a citizen petition from Adapt, the manufacturer of Narcan (naloxone) Nasal Spray, asking that it publish a guidance for...

FDA Accepts AstraZeneca BLA for Bladder Cancer Therapy

[ Price : $8.95]

FDA accepts for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with lo...

FDA Expands Use of Abiomeds Impella CP Heart Pump

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FDA expands approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions...

Gilead Submits NDA for Triple Drug Combo for Hep C

[ Price : $8.95]

Gilead Sciences files an NDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 10...