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Savara Gets Refusal-to-File Letter for Molbreevi BLA

[ Price : $8.95]

FDA issues Savara a Refusal-to-File (RTF) letter for its BLA for Molbreevi (molgramostim) inhalation solution for treating autoimm...

Interchangeability for Celltrions Humira Biosimilar Expanded

[ Price : $8.95]

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

BD Recalls Esophagogastric Balloon Tamponade Tubes

[ Price : $8.95]

BD recalls its Esophagogastric Balloon Tamponade Tubes to update the devices instructions for use due to difficulties in removing ...

FDA Approves Liquidias Pulmonary Hypertension Drug

[ Price : $8.95]

FDA approves Liquidias Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertens...

Susvimo Approved for Diabetic Retinopathy

[ Price : $8.95]

FDA approves Roches Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy.

FDA Backs Covid JN.1-Lineage for Next Boosters

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FDA advises Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially...

Promising Trodelvy Data in Breast Cancer: Gilead

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Gilead Sciences reports promising results from its Phase 3 ASCENT-03 trial evaluating Trodelvy (sacituzumab govitecan-hziy) in pat...

Judge Blocks Mass Federal Layoffs Pending Appeal

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A federal judge extends by two weeks a preliminary injunction halting the Trump administrations plans for further reductions in fo...

Centerline Bio Recalls Catheter Guidewire

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Centerline Biomedical recalls its Intra-Operative Positioning Systems Guidewire 2, a sensorized wire used to navigate through a pa...

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...