NewLink Genetics Gets SPA Approval For Phase 3 Trial In Pancreatic Cancer
The SPA is a written agreement between NewLink as the trial sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of a Phase 3 trial
The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).