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Veru EUA Request for Covid Drug Denied

[ Price : $8.95]

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

Lilly Gets Expanded Indication for Verzenio

[ Price : $8.95]

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

FloSpine 3D-Printed Interbody Cage Cleared

[ Price : $8.95]

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

Convatecs Extracellular Matrix Wound Care Cleared

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

Panel Meeting Nixed on OTC Opioid Reversal Agent

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

FDA Clears Bigfoot Bio Android Diabetes App

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

Noah Medicals Robotic Bronchoscopy Device Cleared

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

CDER 2022 Drug Safety Priorities Report Out

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

FDA, FTC Advancing Biologic Competition

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CDER director Patrizia Cavazzoni describes how FDA and FTC are working collaboratively to increase competition for biologic produc...

Panel to Review Lynparza sNDA for Prostate Cancer

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Federal Register notice: FDA announces a 4/28 Oncologic Drugs Advisory Committee meeting to review an AstraZeneca supplemental NDA...