Shots: The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC. […]readmore
Tags : Approved
Shots: The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced […]readmore
DigiHealth
Regulatory
World’s First App-Based Nicotine Addiction Treatment Receives the MHLW’s Approval
Shots: On Aug 21, 2020, CureApp receives MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The […]readmore
Biosimilars
Regulatory
Amgen and Allergan’s Kanjinti (biosimilar, trastuzumab) Receive the US FDA’s
Shots: The FDA’s approval is based on the totality of evidence which includes extensive comparative analytical, pharmacokinetic and clinical data demonstrating that Kanjinti is highly similar and have no clinical […]readmore