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Device Panel to Review TransMedics Heart System

[ Price : $8.95]

Federal Register notice: FDA announces a 4/6 advisory committee meeting to review a TransMedics PMA for its Organ Care System (OCS...

Learn from Pandemic to Improve FDA Foreign Inspections: GAO

[ Price : $8.95]

The Government Accountability Office will testify 3/4 that FDA needs to learn lessons from the Covid-19 pandemic to improve its ab...

Webstore-USA Marketing Unapproved Covid Serology Test: FDA

[ Price : $8.95]

FDA warns Webstore-USA that it is marketing an unapproved home serology Covid test kit.

Benefit of Investigational Vir/GSK Covid Treatment Questioned

[ Price : $8.95]

VIR and GlaxoSmithKline say a data safety monitoring board has recommended closing the NIH Phase 3 study of their VIR-7831 Covid m...

NurOwn ALS Phase 3 Trial Doesnt Support Benefit: FDA

[ Price : $8.95]

FDA says a Phase 3 trial of BrainStorms NurOwn ALS therapy failed to demonstrate a clinical benefit.

On Target NDA for Ovarian Cancer Illuminator

[ Price : $8.95]

FDA accepts for priority review an On Target Laboratories NDA for pafolacianine sodium injection as an adjunct for identifying ova...

Senhance Surgical System Cleared for General Surgery

[ Price : $8.95]

FDA clears an Asensus Surgical 510(k) for the Senhance Surgical System and its use in general surgery procedures.

Stop Making FDA Registration Certificates: FDA

[ Price : $8.95]

FDA tells 25 companies to stop producing misleading FDA registration certificates used with some medical devices.

FDA Issues Data Modernization Action Plan

[ Price : $8.95]

FDA issues a data modernization action plan with three components.

Shanghai Junshi/Coherus Biosciences Rolling BLA

[ Price : $8.95]

Shanghai Junshi Biosciences and Coherus Biosciences begin a rolling BLA submission for toripalimab for treating recurrent or metas...