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Federal Register notice: FDA makes available a draft guidance on nonclinical safety assessments for oligonucleotide drug products.[ Price : $8.95]
FDA approves an Atamyo Therapeutics IND for a Phase 1b/2b clinical trial involving its ATA-200 gene therapy for treating rare form...[ Price : $8.95]
FDA says it has granted breakthrough device designation to 1,041 devices from 2015 through the 9/30 end of the 2024 fiscal year.[ Price : $8.95]
FDA approves PTC Therapeutics Kibilidi as the first gene therapy to treat aromatic L-amino acid decarboxylase deficiency.[ Price : $8.95]
FDA grants a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring AI-powered atr...[ Price : $8.95]
The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.[ Price : $8.95]
FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotrips...[ Price : $8.95]
FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berku...