Celcuity won FDA approval for gedatolisib (Revtorpyk), a small-molecule PI3K inhibitor, for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who have no PIK3CA mutations and whose disease progressed after prior treatment. The approval covers use in combination with fulvestrant, with or without Pfizer’s Ibrance (palbociclib), giving oncologists a new option built around a previously unmet molecular subgroup.