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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...

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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

Microspecialties Quality System Issues

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

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Biologics

Expand mRNA Covid Vaccine Warnings: FDA

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