Politico explores the many ideas people have for improving FDFA regulation of artificial intelligence.
CDER reports on research into how healthcare providers view and use Boxed Warnings when making treatment decisions for their patients.
Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and its use in treating H...
FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provides current agency sp...
Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive sleep apnea into Cl...
CDER and CBER seek input to help advance the agencys model-informed drug development program.
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently circulating variants...
FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to include preventing mp...
