June 2025 marked a high point in FDA drug approvals with 22 new drugs authorized, tying March for the top monthly volume and contributing to 107 drugs approved in the first half of the year. Key approvals include Gilead’s twice-yearly HIV prophylaxis injection and a ROS1 inhibitor from Nuvation Bio for non-small cell lung cancer. Additionally, Arvinas and Pfizer have filed for regulatory approval of an estrogen receptor-targeting PROTAC, while Novo Nordisk initiated phase III trials for a weight loss amylin/GLP-1 analog combination. This regulatory momentum underscores sustained innovation in both oncology and metabolic disease treatments.