The Association for Diagnostics and Laboratory Medicine raises significant concerns regarding the recent FDA final rule on laboratory-developed tests,...
FDA grants Travere Therapeutics full approval for Filspari (sparsentan) for slowing kidney function decline in adults with primary immunoglobulin A ne...
Federal Register notice: FDA seeks comments on an information collection revision entitled Pharmaceutical Distribution Supply Chain; Drug Supply Chain...
Federal Register notice: FDA makes available a draft guidance entitled Incorporating Voluntary Patient Preference Information over the Total Product L...
Federal Register notice: FDA announces a 10/10 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Stealth BioTherapeutics NDA for e...
GSK says data from its Phase 3 MATINEE clinical trial evaluating chronic obstructive pulmonary disease drug Nucala (mepolizumab) met its primary endpo...
FDA clears an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence technology to assist ...
FDA issues Regenerative Processing Plant a Warning Letter based on a 2023 inspection of the firms Palm Harbor, FL, manufacturing plant that found sign...
