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Senator Concerned About Cybersecurity and Chinese Devices

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Senator Tom Cotton (R-AR) urges FDA and government cybersecurity officials to review Chinese-made medical devices cleared before u...

Seismic Loper Bright Impact Not Yet Seen: Attorneys

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A Yale Journal on Regulation article from the Yale Law School Solomon Center for Health Law & Policy examines how the Supreme Cour...

Early Alert on Abiomed Heart Pump Controller Software Problem

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FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by ...

Guidance Raises Expectations for Form 483 Responses, Expert Says

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A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufactu...

Biogen, Denali Halt Development of Parkinsons Drug in Idiopathic Disease

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Biogen and Denali Therapeutics limit the development of their experimental Parkinsons disease drug BIIB122 after the therapy faile...

FDA OKs Datroway for Triple-Negative Breast Cancer

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FDA approves Daiichi Sankyos Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative bre...

Chronic Hepatitis Delta Virus Infection Treatment Approved

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FDA has approved Gilead Sciences Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking ...

Clarity Sought on FDA New Approach Methodologies Guide

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Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.

React Health Recalls Ventilators Due to Manufacturing Issue

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React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and p...

Bolton Thoracic Stent Recall is Class 1: FDA

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FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.