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Pillar Biosciences PMA Approved for Diagnostic

[ Price : $8.95]

FDA approves a Pillar Biosciences PMA for its oncoReveal Dx Lung and Colon Cancer Assay, a next-generation sequencing tissue-based...

FDA Accepts Keytruda sBLA, Sets Priority Review

[ Price : $8.95]

FDA accepts a Merck sBLA for a new Keytruda melanoma indication and will conduct a priority review.

Eight Medical Recirculator Lavage Kit Recall is Class 1: FDA

[ Price : $8.95]

FDA says the Eight Medical recall of Recirculator 8.0 disposable lavage kits is Class 1.

Eco-Med Pharma Recalls Ultrasound Gel

[ Price : $8.95]

Eco-Med Pharmaceuticals recalls certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination.

OIG Report on Accelerated Approval Due in 2023

[ Price : $8.95]

The HHS Office of Inspector General says it expects to report in 2023 on its review of the FDA accelerated approval pathway.

Specialty Doctors Losing Faith in FDA: Survey

[ Price : $8.95]

A Spherix survey of specialty physicians finds a declining faith in FDA due to specialty-specific experiences with drug approvals ...

FDA Cant Approve Treosulfan NDA in its Present Form: CRL

[ Price : $8.95]

FDA says it cant approve a Medexus NDA for treosulfan in its present form.

FDA Clears Camber Spine Spacers

[ Price : $8.95]

FDA clears a Camber Spine 510(k) for both its Spira-P Posterior Lumbar Spacer technology and Spira-T Oblique Posterior Lumbar Spac...

Rare Disease Firms Urge Accelerated Approval Support

[ Price : $8.95]

The Rare Disease Company Coalition calls on House and Senate leaders to strengthen the FDA accelerated approval pathway and block ...

BD to Start Alaris Software Remediation

[ Price : $8.95]

BD says it will start remediation of a 2020 recall of its Alaris infusion pump system with a new software version.