Despite the success of the PD-1 inhibitor sasanlimab in this setting, adding the PDL-1 inhibitor atezolizumab to intravesical BCG does not improve EFS in naïve patients with high-risk NMIBC, according ...
Enrollment of BCG naïve subjects (QUILT-2.005) receiving BCG alone versus BCG plus ANKTIVA exceeding expectations 85% enrolled with anticipated completion in Q2 2026 with BLA filing to U.S. Food and ...
Following discussions with the U.S. FDA, the Agency recommended that the Company submit additional information for its evaluation of this information to potentially support a resubmission of the sBLA ...
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