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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...

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Human Drugs

Susvimo Approved for Diabetic Retinopathy

FDA approves Roches Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy.

Biologics

FDA Backs Covid JN.1-Lineage for Next Boosters

FDA advises Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially using the LP.8.1 Co...

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Human Drugs

Promising Trodelvy Data in Breast Cancer: Gilead

Gilead Sciences reports promising results from its Phase 3 ASCENT-03 trial evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with first-lin...

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FDA General

Judge Blocks Mass Federal Layoffs Pending Appeal

A federal judge extends by two weeks a preliminary injunction halting the Trump administrations plans for further reductions in force at FDA and 21 ot...

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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.