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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.

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...