FDA says it no longer requires a cardiovascular outcome trial for Vivus Qsymia weight-loss pill.
FDA sends PharmaTher a complete response letter on its ANDA for Ketarx (ketamine) and its use in anesthesia, sedation, and pain, among other uses.
FDA grants Distalmotion a de novo marketing authorization for the Dexter Surgical Robot for adult inguinal hernia repair.
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.
