FDA clears a Paragonix Technologies 510(k) for its transportable perfusion device KidneyVault and its use in kidney preservation.
House Republicans demand the release of clinical data from taxpayer-funded research involving a study of puberty-blocking drugs that were not publishe...
Federal Register notice: FDA seeks comments on an information collection extension entitled Antimicrobial Animal Drug Sales and Distribution21 CFR 514...
A bipartisan Congressional effort seeks broader FDA interpretations when awarding priority review vouchers.
FarmaKeio Outsourcing, a drug compounding outfit, files a lawsuit against FDA seeking a court order to permit the compounding of sodium thiosulfate.
FDA approves Medtronics Affera Mapping and Ablation System with Sphere-9 Catheter for treating persistent atrial fibrillation.
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related applications.
