FDA creates a new CARES Act Amount Information Reporting application for drug establishments to use when submitting (xxx insert, delete xxx) annual re...
FDA rejects an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approved multiple myeloma dr...
New York attorney general Letitia James urges FDA to take further safety actions to address the dangers of Mercks Singilair (montelukast) and generics...
BrainStorm Cell Therapeutics files a Special Protocol Assessment request for a Phase 3b study of NurOwn, its investigational treatment for amyotrophic...
FDA accepts for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult p...
FDA issues Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a beta-lactam/beta-la...
FDA clears a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury.
FDA says it has responded to a Universities Allied for Essential Medicines by creating a dashboard of Clinical Trials.gov pre-notice letters on potent...
