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Neurovalens Insomnia Neurostimulation Cleared

[ Price : $8.95]

FDA clears a Neurovalens 510(k) for its Modius Sleep neurostimulation device for treating chronic insomnia.

Foradil Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn ...

CDRH Endorses Device Cybersecurity Standard

[ Price : $8.95]

CDRH says it has recognized and supports industrys use of a key consensus standard "ANSI/AAMI SW96:2023 Standard for medical devic...

Teleflex/Arrow Recall Catheter Kits

[ Price : $8.95]

Teleflex and subsidiary Arrow International recall their Pressure Injectable Catheter Kits due to mislabeling about the presence o...

Petition Seeks to Block Vigabatrin Exclusivity

[ Price : $8.95]

Law firm Sidley petitions FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity to Pyros Pharmaceuti...

Kodiak Plans Another Study on Eye Drug

[ Price : $8.95]

Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three e...

Phathom Gets Approval for GERD Drug

[ Price : $8.95]

FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker...

Submitting PRO Data in Cancer Trials Guide

[ Price : $8.95]

FDA posts a final guidance entitled Submitting Patient-Reported Outcome Data in Cancer Clinical Trials.

Some Clinical e-Thermometers to Be Exempt

[ Price : $8.95]

Federal Register notice: FDA identifies certain Class 2 clinical electronic thermometers that, when this action is finalized, will...

House Oversight Panel Probes Drug Shortages

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The House Committee on Oversight and Accountability calls on FDA to provide extensive information on its response to a growing num...