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 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...
