FDA issues a safety alert about cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronics im...
FDA makes available a draft guide entitled Rare Diseases: Natural History Studies for Drug Development.
FDA clears a Genetesis 510(k) clearance for its cardiac imaging platform, which pairs its CardioFlux Magnetocardiograph with the integrated Faraday An...
CDERs Office of Clinical Pharmacology (OCP) says that in 2019 it will focus on current health issues related to the opioid epidemic, antimicrobial res...
Federal Register notice: FDA announces a 4/26 Antimicrobial Drugs Advisory Committee meeting to discuss the safety and effectiveness of bacitracin for...
FDA issues a safety alert on the investigational use of AbbVie/Genentechs Venclexta (venetoclax) for treating patients with multiple myeloma based on ...
FDA issues Lexicon Pharmaceuticals and Sanofi a complete response letter on their NDA for investigational Zynquista (sotagliflozin), a dual SGLT1 and ...
FDA issues Recro Pharma a complete response letter for intravenous meloxicam for managing moderate to severe pain.