The FDA approved 22 drugs in June 2025, tying a recent high and contributing to a strong first-half performance with 107 total approvals. Key regulatory decisions include the agency’s rejection of Roche’s label expansion for Columvi due to insufficient data and a panel's recommendation against Otsuka’s PTSD treatment combining Rexulti and Zoloft following equivocal phase III results. Notably, Biocon won FDA's first interchangeable biosimilar status for its Novolog biosimilar Kirsty. Advisory votes also blocked GSK’s Blenrep comeback for multiple myeloma over safety and trial concerns.