The FDA started July strongly with multiple approvals and pending decisions. Three new molecular entities (NMEs) were approved in June, bringing the yearly total to 19 with additional approvals expected. Cochlear Ltd received clearance for its Nucleus Nexa System, the first smart cochlear implant. The FDA opened negotiations on the next generic drug user fee agreement and released partial CRLs for approved drugs. New legislation aims to extend Hospital-at-Home reimbursement through 2030, ensuring continuity for acute care delivery at home. These activities reflect ongoing regulatory dynamism across drug, device, and care delivery sectors.