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New York attorney general Letitia James urges FDA to take further safety actions to address the dangers of Mercks Singilair (monte...[ Price : $8.95]
BrainStorm Cell Therapeutics files a Special Protocol Assessment request for a Phase 3b study of NurOwn, its investigational treat...[ Price : $8.95]
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.