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Asensus Surgical Recalls Robot Devices

[ Price : $8.95]

Asensus Surgical recalls its Senhance Surgical System due to malfunctions that cause unintended movement of the robotically assist...

Braun Medical Infusion Pump Recall

[ Price : $8.95]

Braun Medical recalls its Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms.

FDA Approves Expanded Xtandi Use

[ Price : $8.95]

FDA approves Astellas Pharmas Xtandi (enzalutamide) for an expanded use treating non-metastatic castration-sensitive prostate can...

BMS Gains Approval for Lung Cancer NDA

[ Price : $8.95]

FDA approves a Bristol Myers Squibb NDA for Augtyro (repotrectinib) for treating adult patients with locally advanced or metastati...

Regulatory Review Determination on Rozlytrek Corrected

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Federal Register notice: FDA corrects a notice that appeared in the 7/8/2022 Federal Register that announced an agency determinati...

Panel to Tackle Pulse Oximeter Quality

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Federal Register notice: FDA announces a 2/2/2024 advisory committee meeting to discuss pulse oximeter quality.

Device Discontinuance and 506J List Guidances

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FDA issues one final and one draft guidance related to Section 506J notifications of medical device shortages.

FDA Publishes 40 Product-Specific Guidances

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FDA publishes 22 new and 18 revised product-specific guidances for developing generic drugs.

Device Computational Modeling Credibility Guide

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FDA publishes a guidance to help in assessing the credibility of computational modeling and simulation in medical device submissio...

U.S. Drug Shortages Increasing: Report

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An Iqvia Institute report says drug shortages continue to increase in the U.S., with the number of new shortages outpacing the num...