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MAHA Assessment Details Childrens Health Crisis

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

Makary Takes Heat for Budget, Mass Firings at Hearing

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A Senate appropriations hearing criticizes FDA commissioner Marty Makary over secrecy about the agencys fiscal year 2026 budget pr...

GAO Faults FDA Organ-on-a-Chip Regulation

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

Biocompatibility Testing Labs Falsified Data: FDA

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

Serious Research Issues at United Health Products: FDA

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

Microspecialties Quality System Issues

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FDA warns Middletown, CT-based Microspecialties about Quality System violations in its work as a contract manufacturer of several ...

Expand mRNA Covid Vaccine Warnings: FDA

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FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in y...

Bipartisan Bill to Codify Trump Drug Price Order

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Four House members introduce bipartisan legislation to legalize major provisions in President Trumps drug pricing executive order....

Panel is Split on UroGens Bladder Cancer Drug

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FDAs Oncologic Drugs Advisory Committee offers a split vote on whether UroGen Pharmas NDA for mitomycin intravesical solution demo...

Zynex Files 510(k) for CO-Oximeter Device

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Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the companys laser technology.