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Human Drugs

GSKs Nucala Approved for Certain COPD Patients

FDA approves GSKs Nucala (mepolizumab) as an add-on maintenance treatment for certain adults with chronic obstructive pulmonary disease.

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Medical Devices

Centerline Bio Recalls Catheter Guidewire

Centerline Biomedical recalls its Intra-Operative Positioning Systems Guidewire 2, a sensorized wire used to navigate through a patients vasculature....

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Human Drugs

MAHA Assessment Details Childrens Health Crisis

The Presidents Make America Healthy Again Commission issues an assessment of the drivers of what it says is a childrens health crisis.

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Human Drugs

Makary Takes Heat for Budget, Mass Firings at Hearing

A Senate appropriations hearing criticizes FDA commissioner Marty Makary over secrecy about the agencys fiscal year 2026 budget proposal, which calls ...

FDA General

GAO Faults FDA Organ-on-a-Chip Regulation

A Government Accountability Office report says FDA needs to improve its understanding and regulation of organs-on-a-chip.

Medical Devices

Biocompatibility Testing Labs Falsified Data: FDA

FDA says it will reject all data coming from biocompatibility testing labs Mid-Link Technology Testing and Sanitation & Environment Technology Institu...

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Medical Devices

Serious Research Issues at United Health Products: FDA

FDA warns Mt. Laurel, NJ-based United Health Products about serious violations in its clinical study of the CelluSTAT absorbable hemostat.

Biologics

Moderna Withdraws Pending BLA for Flu/Covid Vaccine

Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.

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Medical Devices

QS Violations in NeuroSync Inspection

FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync eye assessment medic...

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Medical Devices

Ethicon Endo-Surgery Recalls Surgical Stapler

Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical stapler due to increase...