Biotech News
ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel
FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetes FDA also confirmed that the ongoing Phase 3 PROACT 1 study can be used for both accelerated approval and for full approval Nearly half of the patients