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Nova Bio Recalls Glucose Meters

[ Price : $8.95]

Nova Biomedical recalls its StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error m...

Roche Sexual Disease Assay Panels Cleared

[ Price : $8.95]

FDA clears a Roche 510(k) clearance for its cobas liat sexually transmitted infection multiplex assay panels.

Trial Speed Seen as Key to Accelerated Approvals

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In an online post, three Hyman, Phelps attorneys say two new FDA guidances show how the agency plans to enforce its requirement th...

Merck Stopping Winrevair Trial as Benefit Is Already Seen

[ Price : $8.95]

Mercks ends the HYPERION trial of Winrevair early due to positive results from earlier trials so all participants can receive the ...

Multiple Violations Cited at ProRx Outsourcing Facility

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FDA warns Exton, PA-based ProRx about multiple violations in its production of drugs as an outsourcing facility.

Cybersecurity Vulnerabilities in 2 Patient Monitors

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An FDA safety communication warns about cybersecurity vulnerabilities in Contec and Epsimed patient monitors.

Committee Chair Struggles to Support Kennedy

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Senate Health Education Labor & Pensions Committee chair Bill Cassidy (R-LA) says he is having a difficult time believing HHS secr...

FDA Approves Axsomes Migraine Drug

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FDA approves Axsome Therapeutics Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in ...

FDA Clears Roche Lipoprotein (a) Assay

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FDA clears a Roche 510(k) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay that measures lipoprotein (a) in nanomoles per l...

Breakthrough Status for Meniscus Knee Implant

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FDA grants OrthoPreserve a breakthrough device designation for its Defender meniscus replacement knee implant.