Chart: FDA Recalls & Court Actions
This article was originally published in The Gray Sheet
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A Phase III trial testing dapagliflozin in chronic kidney disease patients with and without diabetes was stopped early following a recommendation from an independent data monitoring committee.
Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.
Three-month results of the SPYRAL HTN-OFF MED pivotal trial show renal denervation with Medtronic’s Symplicity Spyral system significantly reduced blood pressure in hypertensive patients not taking anti-hypertensive medications.