FDA issues Recro Pharma a complete response letter for intravenous meloxicam for managing moderate to severe pain.
Federal Register notice: FDA announces a 4/8 public workshop entitled Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacte...
Researchers say they have found a way to use a nano-bomb to potentially treat triple negative breast cancer.
Biogen and Eisai discontinue global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mil...
FDA clears a GenePOC 510(k) for the GenePOC Strep A assay for use on its revogene device.
CDER Office of Medical Policy director Jacqueline Corrigan-Curray uses a Webinar to explain how the Center is approaching the collection and use of re...
FDA approves an Impulse Dynamics PMA for the Optimizer Smart system for treating certain patients with chronic, moderate-to-severe heart failure.
FDA grants Enzyvant rare pediatric disease and fast track designations for RVT-801, an investigational enzyme replacement therapy.