The year has been significant for the FDA, with notable approvals and reforms shaping the biopharma landscape. In 2025, the FDA announced 58 novel approvals, marking a steady pace despite challenges. Key decisions included impactful treatments that have been highlighted in various reviews, emphasizing their importance for fields such as neurology and ophthalmology. As the FDA prepares for anticipated approvals in 2026, experts reflect on the trends and changes of the past year and how they will influence future regulatory actions.