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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.

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.

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...