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Merck Stopping Winrevair Trial as Benefit Is Already Seen

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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.

Orphan Drug Designation for Marsh Lymphoma Drug

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FDA grants orphan drug designation to March Biosciences MB-105 to treat relapsed/refractory CD5-positive T-cell lymphoma.

Adial Finishes Alcohol Abuse Drug PK Study

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Adial Pharmaceuticals reports positive results from its pharmacokinetic study of ondansetron to treat alcohol use disorder

Trust in Health Agencies Continues Decline: KFF

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The latest Kaiser Family Foundation health information and trust tracking poll sees a continuing decline in public trust in FDA an...