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.
Novo Nordisk files two NDAs for oral semaglutide, the first once-daily, glucagon-like, peptide-1 receptor agonist in a pill.
FDA approves a Jazz Pharmaceuticals NDA for Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associate...
A current and a retired FDA physician advisor say there should be a moratorium on agency approval of any new or reformulated opioids until FDA impleme...
CDER director Janet Woodcock says a Center reorganization involving four Offices has been approved.
Soliton files a 510(k) for the Rapid Acoustic Pulse (RAP) tattoo removal device.