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FDA Clinical Hold on Magenta Trial

[ Price : $8.95]

FDA places a clinical hold on a Magenta Therapeutics Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia ...

Vero Biotech Recalls Nitric Oxide System

[ Price : $8.95]

Vero Biotech recalls its Genosyl DS; Nitric Oxide Delivery System due to a software issue that leads to errors in gas delivery.

Woodcock Touts Medical Device Actions

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FDA acting commissioner Janet Woodcock discusses new agency plans to better secure the medical device supply chain.

Dahlia Center Offering Cellular Product to Treat Covid-19: FDA

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The CBER Office of Compliance and Biologics Quality cautions The Dahlia Center that it is marketing unapproved cellular products.

Jordans Crossing Selling Unapproved, Misbranded Covid Products: FDA

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FDA says Jordans Crossing Herbal Connection is marketing a misbranded unapproved new drug intended to prevent or treat Covid-19.

Bladder Cancer Test Gets Breakthrough Status

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FDA grants AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA m...

Draft Remanufacturing Guidance Falls Short: Mintz Analysis

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Mintz attorneys say an FDA draft medical device remanufacturing guidance fails to give information that entities need to determine...

Genentech Breakthrough for Myelodysplastic Drug

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FDA grants Genentech a breakthrough therapy designation for Venclexta (venetoclax) in combination with azacitidine for treating ad...

Zoll Brain Injury Dashboard Cleared

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FDA clears a Zoll Medical 510(k) for its TBI Dashboard feature on its Propaq M monitor and Propaq MD monitor/defibrillator for man...

Covis Seeks FDA Actions on Eugia Pharma ANDA

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Covis asks FDA to determine that Eugia should have filed a 505(b)(2) NDA rather than an ANDA for its proposed generic form of Covi...