Karuna Therapeutics plans a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline results from a recent Pha...
FDA and RTI International researchers review empirical studies of prescription drug promotion in the last decade and suggest areas for further study.
FDA clears a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence tool for stroke diagnoses.
FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic aneurysms.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Esperoct (antihemophilic factor (...
Federal Register notice: FDA amends certain medical device regulations to update mailing addresses and docket numbers.
FDA approves a Sandoz supplemental BLA for citrate-free Hyrimoz (adalimumab-adaz) injection, a biosimilar version of Abbvies Humira.
The International Council for Harmonization approves the S12 guidance on nonclinical biodistribution studies for gene therapy products.
