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Human Drugs

Merck Stopping Winrevair Trial as Benefit Is Already Seen

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

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Human Drugs

Multiple Violations Cited at ProRx Outsourcing Facility

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

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Medical Devices

Cybersecurity Vulnerabilities in 2 Patient Monitors

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

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FDA General

Committee Chair Struggles to Support Kennedy

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

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Human Drugs

FDA Approves Axsomes Migraine Drug

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

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Human Drugs

FDA Clears Roche Lipoprotein (a) Assay

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

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Medical Devices

Breakthrough Status for Meniscus Knee Implant

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

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Human Drugs

Orphan Drug Designation for Marsh Lymphoma Drug

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

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Human Drugs

Adial Finishes Alcohol Abuse Drug PK Study

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

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FDA General

Trust in Health Agencies Continues Decline: KFF

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