FDA gives Genentech’s Gazyva Priority Review for primary membranous nephropathy
FDA Priority Review puts Genentech’s Gazyva on a November decision path in primary membranous nephropathy after the Phase III MAJESTY win.
Pharma & Biotech
Pharma & Biotech
City Therapeutics raises $99.5m as CITY-FXI and CITY-RBP4 head toward key tests
City Therapeutics has fresh capital, but RNAi’s next test is tissue delivery. See why CITY-FXI and CITY-RBP4 matter now.
Features & Analysis
Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.