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Daiichi Sankyo Drug OKd for Lung Cancer

[ Price : $8.95]

FDA approves a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for certain adults with locally advanced or metastati...

Medline Issues Correction for Procedure Kits

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Medline Industries recalls certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to ...

Dupixent Approved for Bullous Pemphigoid

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FDA has approved Sanofi and Regenerons Dupixent (dupilumab) for treating adult patients with bullous pemphigoid that mainly affect...

Monjuvi Approved for Follicular Lymphoma

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FDA approves Incytes Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed o...

FDA Clears DeepEcho AI Fetal Ultrasound

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FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.

Cycles Harliku Approved for Alkaptonuria

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FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients w...

Is FDA Going After RUO Diagnostics?

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Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling resear...

FDA Halts Some Cell Clinical Trials

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FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological mater...

Top 2 FDA Cell/Gene Therapies Officials Pushed Out

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FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the...

Securing Technology, Equipment Report

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The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advan...