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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...

Animal Drugs

Interchangeability for Celltrions Humira Biosimilar Expanded

FDA grants an expanded interchangeable designation for Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.

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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...

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

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....