FDA grants an accelerated approval to Novartis for its supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly diagnose...
Former president Donald Trump appears to be leaning toward elevating former presidential candidate and now supporter Robert F. Kennedy, Jrs health rol...
FDA says it no longer requires a cardiovascular outcome trial for Vivus Qsymia weight-loss pill.
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.
