Shots: The P-III CheckMate -274 study involves assessing of Opdivo vs PBO in 709 patients in a ratio (1:1) with muscle-invasive urothelial cancer at a high risk of recurrence after […]readmore
Tags : High-Risk
Shots: The approval is based on KEYNOTE-057 (NCT02625961) study involves assessing of Keytruda (200 mg, q3w) in 96 patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in […]readmore
Shots: The US FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 9-4 in favor of recommending Keytruda for bacillus Calmette-Guérin-unresponsive, high risk NMIBC with carcinoma in-situ with/ out papillary tumors […]readmore
Shots: The application is based on P-II KEYNOTE-057 trial which involves assessing of Keytruda (200mg, q3w) in 102 patients with BCG unresponsive, high-risk NMIBC with carcinoma in-situ (CIS) with/out papillary […]readmore
Shots: The US FDA has granted FT designation to the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery […]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
Shots: The approval from Japanese Ministry of Health is based on two P-III study FRAME & BRIDGE assessing Evenity (210mg) vs PBO in 7,180 & 245 postmenopausal women with osteoporosis & […]readmore
Shots: The EU approval is based on results of P-III PROSPER trial assessing Xtandi+ ADT vs. PBO + ADT in patients with nmCRPC and PSA level The P-III PROSPER trial […]readmore