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FDA OKs Syndax Pharm Leukemia Drug

[ Price : $8.95]

FDA approves a Syndax Pharmaceuticals NDA for Revuforj (revumenib), a menin inhibitor for treating relapsed or refractory acute le...

RFK Jr. Aims to Free FDA from Corporate Capture

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HHS secretary-nominee Robert F. Kennedy Jr. vows to free the agencies, including FDA, from the smothering cloud of corporate captu...

Dupixent Supplemental BLA Filed for Urticaria

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FDA accepts for review a Sanofi and Regeneron supplemental BLA resubmission for Dupixent (dupilumab) for treating chronic spontane...

Guide on Nonclinical Safety for Oligonucleotides

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Federal Register notice: FDA makes available a draft guidance on nonclinical safety assessments for oligonucleotide drug products.

Atamyo OKd for Gene Therapy Trial

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FDA approves an Atamyo Therapeutics IND for a Phase 1b/2b clinical trial involving its ATA-200 gene therapy for treating rare form...

More Than 1,000 Breakthrough Device Designations

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FDA says it has granted breakthrough device designation to 1,041 devices from 2015 through the 9/30 end of the 2024 fiscal year.

FDA Approves PTC Therapeutics Kebilidi

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FDA approves PTC Therapeutics Kibilidi as the first gene therapy to treat aromatic L-amino acid decarboxylase deficiency.

Home AFib Blood Pressure Monitor De Novo Granted

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FDA grants a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring AI-powered atr...

Medical Device Recalls Up, Drugs Down: Sedgwick

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The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.

SonoMotion De Novo for Stone Clear Ultrasound

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FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotrips...