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Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three e...[ Price : $8.95]
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker...[ Price : $8.95]
FDA posts a final guidance entitled Submitting Patient-Reported Outcome Data in Cancer Clinical Trials.[ Price : $8.95]
Federal Register notice: FDA identifies certain Class 2 clinical electronic thermometers that, when this action is finalized, will...[ Price : $8.95]
The House Committee on Oversight and Accountability calls on FDA to provide extensive information on its response to a growing num...[ Price : $8.95]
FDA accepts for review a Supernus Pharmaceuticals NDA resubmission for its apomorphine infusion device (SPN-830) for the continuou...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.[ Price : $8.95]
FDA clears an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform pulse and respiratory ra...