FDA Clears Celcuity’s Gedatolisib, Marking Company's First Marketed Therapy
The U.S. Food and Drug Administration approved gedatolisib, marketed as Revtorpyk, for a defined group of advanced breast cancer patients. The approval, based on late-stage trial data, covers use of Revtorpyk in combination with Pfizer's Ibrance and fulvestrant and follows evidence of a substantial reduction in the risk of disease progression or de…