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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

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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

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

Some Clinical e-Thermometers to Be Exempt

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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...

Supernus Parkinsons Off Episodes NDA Refiled

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FDA accepts for review a Supernus Pharmaceuticals NDA resubmission for its apomorphine infusion device (SPN-830) for the continuou...

Guide on Clinical e-Thermometer

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Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.

Empatica Adds 2 Biomarkers to Monitoring Device

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FDA clears an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform pulse and respiratory ra...

House GOPers Concerned About FDA Lab Safety

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Republican members of the House Energy and Commerce Committee express concern about FDA inaction on the safety of agency laborator...

Hold on Nurix B-cell Malignancies Study

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A transition to an improved manufacturing process leads to an FDA partial clinical hold on a Nurix Therapeutics clinical study eva...