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Getinge PMA Approved for Iliac Artery Stent

[ Price : $8.95]

FDA approves a Getinge PMA for its iCast covered stent system for treating patients with iliac arterial occlusive disease.

Dose Optimization Info for Combo Drugs Needed: PhRMA

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Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic drug development provides limit...

Incyte Complete Response on Once-daily Jakafi

[ Price : $8.95]

FDA issues Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JAK1/JAK2 inhibitor for once-dai...

Comments Sought on REMS Modification Requests

[ Price : $8.95]

Federal Register notice: FDA establishes a docket to solicit comments on factors that should be considered when reviewing risk eva...

Panel Backs Accelerated OK Consideration of Biogen's ALS Drug

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An FDA advisory committee votes 9 to 0 that Biogens amyotrophic lateral sclerosis drug tofersen should be considered for accelerat...

FDA Digital Health Technologies Framework

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As required by the PDUFA 7 agreement, FDA publishes a framework for how it will implement a multifaceted program for using digital...

Xtrava Covid Test Less Effective with Some Variants: FDA

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FDA adds the Xtrava Health SPERA Covid-19 test to the list of tests expected to have a reduced performance with certain Covid-19 O...

Unibody Endografts Dont Beat Older Ones: Study

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FDA-funded research finds that unibody endografts are not non-inferior to non-unibody devices, leading to updated FDA labeling.

FDA Reminds on Recalled Exactech Joint Devices

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FDA reminds patients and healthcare providers about risks associated with recalled Exactech replacement joint devices that were pa...

Dupixent Meets Key Phase 3 Endpoints: Regeneron

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Regeneron and Sanofi say an investigational Phase 3 trial of Dupixent in some COPD patients met all key primary and secondary endp...