The FDA’s June approvals included 22 drugs, equaling the March total and pushing 2025 into the third-highest year on record for new drug approvals at midyear. Notable approvals include Gilead’s twice-yearly HIV prevention injection and Nuvation Bio’s ROS1 inhibitor for non-small cell lung cancer. Pipeline movement also involves Arvinas and Pfizer’s estrogen receptor-targeting PROTAC filing and Monte Rosa’s planned Phase 1 trial for a NEK7 degrader aimed at inflammatory diseases. Novo Nordisk is advancing pivotal Phase 3 trials of an amylin analog/GLP-1 combo for weight loss. Altimmune’s GLP-1/glucagon dual receptor agonist likewise showed improvements in measures of MASH in Phase 2, indicating ongoing innovation across therapeutic areas from oncology to metabolic and inflammatory conditions.
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