FDA clears a SIG Medical 510(k) for its AdvantageRib Anterior System, intended for the fixation, stabilization, and fusion of rib fractures and osteot...
Federal Register notice: FDA determines that 47 drug products it is listing were not withdrawn from sale for reasons of safety or effectiveness.
FDA and Duke-Margolis Health Policy Center plan an 11/27 public meeting to seek stakeholder input on long-term solutions to address the drug shortage ...
FDA approves an expanded label for Novartis Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and old...
FDA alerts health care professionals and patients not to use drug products produced and distributed by Pharm D Solutions (Houston, TX) due to lack of ...
FDA responds to a petition to allow a new qualified health claim for edible oils containing high levels of oleic acid, a monounsaturated fat that has ...
Federal Register notice: FDA submits to OMB an information collection extension for General Licensing Provisions; Section 351(k) Biosimilar Applicatio...
FDA issues Aquestive Therapeutics a complete response letter on its NDA tadalafil oral film, a PDE5 inhibitor currently marketed (Eli Lillys Cialis) i...