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FDA Clears TrainHealths Neuromuscular Stimulator

[ Price : $8.95]

FDA clears a TrainHealth 510(k) for its TrainFES neuromuscular stimulator and its use in treating people with sequelae of stroke a...

FDA Loses on Regulating Lab-Developed Tests

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Eastern Texas federal judge Sean Jordan rules against FDA in a case challenging the agencys final rule regulating laboratory-devel...

Marks Firing Challenges RFK Jr.s Fitness for Office

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FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and va...

Corcepts Relacorilant Shows Promise in Ovarian Cancer

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Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-pacli...

Medtronic Recalls Aortic Root Cannulas

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Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device...

Smallpox/Mpox Vaccine OKd Despite CBER Turmoil

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FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Pe...

Milestone Misses Approval on Irregular Heart Beat NDA

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FDA sends Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to con...

FDA Green Lights At-Home Sexual Disease Test

[ Price : $8.95]

FDA grants Visby Medical a de novo marketing clearance for its Womens Sexual Health Test, a non-prescription at-home diagnostic te...

Meeting on Opioid Postmarketing Studies Set for 5/5

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FDA reschedules for 5/4 a previously planned joint advisory committee meeting on studies that looked at the use of opioid analgesi...

Novartis Wins Expanded Pluvicto Use in Prostate Cancer

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FDA approves a Novartis supplemental NDA to expand the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include ...