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Medical Devices

BD Recalls Esophagogastric Balloon Tamponade Tubes

BD recalls its Esophagogastric Balloon Tamponade Tubes to update the devices instructions for use due to difficulties in removing plastic plugs from i...

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Human Drugs

FDA Approves Liquidias Pulmonary Hypertension Drug

FDA approves Liquidias Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertension and pulmonary hy...

Animal Drugs

Accelerated Approval Works: Friends of Cancer Research

A Friends of Cancer Research online data analysis shows the FDA accelerated approval program is working as designed to speed innovative drugs to the m...

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Human Drugs

Tariffs Could Hurt Drug Supply: HuffPost

A HuffPost report says a tariff on imported drugs could lead to shortages of medications that patients need.

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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...