Japan has approved the Leqembi Pen for once-weekly at-home administration in early Alzheimer’s disease, potentially reducing infusion-center dependence while giving Biogen and Eisai another way to differentiate lecanemab from rival anti-amyloid therapies.
Stoke Therapeutics and Biogen say four-year zorevunersen data show durable seizure reductions plus continuing cognitive and behavioral improvements as Phase 3 EMPEROR advances.
FDA Priority Review puts Genentech’s Gazyva on a November decision path in primary membranous nephropathy after the Phase III MAJESTY win.
City Therapeutics has fresh capital, but RNAi’s next test is tissue delivery. See why CITY-FXI and CITY-RBP4 matter now.
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.