Ionis Pharmaceuticals reports positive topline results from the Essence study of olezarsen in people with moderate hypertriglyceridemia.
FDA approves a Novavax BLA for traditional approval of Nuvaxovid for active immunization to prevent Covid-19 that includes a more limited intended pat...
An FDA safety alert warns that patients who stop taking oral allergy medicines cetirizine or levocetirizine after long-term use may experience rare bu...
FDA clears a Stryker 510(k) for its OptaBlate basivertebral nerve ablation system and its use for procedures providing vertebrogenic pain relief.
FDA lifts a clinical hold against Scynexiss ibrexafungerp that will allow it to proceed with its Phase 3 MARIO study in invasive candidiasis and candi...
FDA accepts for review a Travere Therapeutics supplemental NDA for traditional approval of Filspari (sparsentan) for treating focal segmental glomerul...
FDA clears a Fujirebio Diagnostics 510(k) for the first in vitro diagnostic device that tests blood in diagnosing Alzheimers disease.
FDA posts briefing documents outlining issues to be discussed during a two-day (5/20-21) Oncologic Drugs Advisory Committee meeting that is reviewing ...
