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FDA said it never inspected dental lab that made controversial AGGA device
San Jose Mercury News· 4 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements | JD Supra
JD Supra· 19 hours agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed ...
FDA greenlights SAB Biotherapeutics' diabetes drug trial By Investing.com
Investing.com· 10 hours agoThe U.S. Food and Drug Administration (FDA) has cleared SAB Biotherapeutics' investigational new...
US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
AOL· 12 hours agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer and help detect it in earlier stages, potentially helping cure patients and prolong survival ...
Larimar's Friedreich's ataxia program free at last from FDA hold
FierceBiotech· 12 hours agoLarimar Therapeutics’ Friedreich’s ataxia program is free at last, with the FDA fully lifting a...
FDA lifts hold on Larimar's Friedreich's Ataxia drug study By Investing.com
Investing.com· 22 hours agoLarimar Therapeutics, Inc. (NASDAQ:LRMR), a biotechnology firm engaged in developing treatments for...
Roche Breast Cancer Medicine to Get Expedited FDA Review
Bloomberg· 15 hours agoRoche Holding AG said an experimental breast-cancer treatment will get an expedited review from US...
US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters· 11 hours ago, opens new tab experimental blood test for a cancer of colon or rectum may fail to detect some...
What's Going On With Colorectal Cancer Diagnostic-Focused Guardant Health Stock On Tuesday?
Benzinga· 5 hours agoTuesday, the FDA's staff reviewers raised concerns regarding Guardant Health Inc's GH experimental...
FDA issues recall notice for Philips after another respiratory device fails
Medical Device Network via Yahoo Finance· 7 days agoThe FDA has issued the notice for the company’s Trilogy EVO Continuous Ventilators, warning that...
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