Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to […]readmore
Tags : 89Zr-girentuximab
Shots: The US FDA has granted BTD for Telix’s renal cancer imaging product TLX250-CDx (89Zr-girentuximab) Under BTD, the FDA will work closely with Telix to provide guidance on the development […]readmore