Rextoro regulatory update

FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees voted against approval of Rextoro oral testosterone from Clarus. The committees voted 18-3 that Rextoro's overall risk/benefit is insufficient to support approval as replacement therapy in testosterone-deficient men and 12-8 that its efficacy evidence is insufficient. The PDUFA date is Nov. 3. ...