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FDA accepts for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatmen...[ Price : $8.95]
FDA issues Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a...[ Price : $8.95]
FDA clears a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury.[ Price : $8.95]
FDA rejects an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approved...[ Price : $8.95]
FDA says it has responded to a Universities Allied for Essential Medicines by creating a dashboard of Clinical Trials.gov pre-noti...[ Price : $8.95]
FDA clears a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling.[ Price : $8.95]
FDA clears a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery.[ Price : $8.95]
Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Drug Promotion research into impl...