Shots: The P-III studies SKYLIGHT 1 & 2 involves assessing fezolinetant (30 & 45mg, qd) vs PBO in women with mod. to sev. vasomotor symptoms (VMS) for the first 12wks. […]readmore
Tags : Postmenopausal Women
Shots: The EC has granted MAA to Evenity for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture, following the CHMP’s positive opinion received in Oct’2019 […]readmore
Shots: The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Evenity (romosozumab) based on P-III global studies including FRAME, ARCH and BRIDGE studies assessing Evenity vs PBO […]readmore
Shots: The approval of EVENITY is based on two P-III study results FRAME and ARCH. FRAME and ARCH involved assessing of EVENITY (210 mg) vs PBO and EVENITY (210 mg) […]readmore
Regulatory
Amgen’s Evenity (romosozumab-aqqg) Receives FDA’s Approval for Osteoporosis in Postmenopausal
Shots: The FDA’s approval is based on two P-III FRAME & ARCH studies result assessing Evenity (210mg) vs PBO & alendronate (70mg) in 7,180 & 4,093 postmenopausal women with osteoporosis […]readmore