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Human Drugs

Panel to Weigh OTC Phenylephrine Efficacy

FDA announces a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-the-counter use of o...

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Human Drugs

Exelixis Renal Cell Carcinoma Study Misses Endpoint

Exelixis says its Phase 3 CONTACT-03 study evaluating the companys Cabometyx (cabozantinib) in combination with atezolizumab versus cabozantinib alone...

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Human Drugs

Veru EUA Request for Covid Drug Denied

FDA declines a Veru request for an Emergency Use Authorization for sabizabulin, a microtubule disruptor for treating Covid-19 hospitalized adult patie...

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FDA General

Lilly Gets Expanded Indication for Verzenio

FDA approves an expanded indication for Eli Lillys Verzenio (abemaciclib), in combination with endocrine therapy for the adjuvant treatment of adult p...

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Medical Devices

FloSpine 3D-Printed Interbody Cage Cleared

FDA clears a FloSpine 510(k) for its a 3D-printed titanium Ti-Largo cervical interbody cage system to support the spine after a cervical collapse or a...

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Medical Devices

Convatecs Extracellular Matrix Wound Care Cleared

FDA cleared a Convatec 510(k) for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management.

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Human Drugs

Panel Meeting Nixed on OTC Opioid Reversal Agent

Federal Register notice: FDA cancels for undisclosed reasons a 3/20 joint meeting of the Nonprescription Drugs Advisory Committee and Anesthetic and A...

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Human Drugs

FDA Clears Bigfoot Bio Android Diabetes App

FDA clears a Bigfoot Biomedical 510(k) for the Android version of the Bigfoot Unity Mobile App, which is a part of the Bigfoot Unity Diabetes Manageme...

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Medical Devices

Noah Medicals Robotic Bronchoscopy Device Cleared

FDA clears a Noah Medical 510(k) for the Galaxy System, a robotic-navigated bronchoscopy device and accessories that are intended to provide bronchosc...

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Human Drugs

CDER 2022 Drug Safety Priorities Report Out

FDA publishes the CDER Drug Safety 2002 Priorities Report reviewing the many drug safety activities the Center undertook in 2022.