The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
The study showed a 76% complete response (CR) rate at 12 months, rising to 95% at any time for high-risk NMIBC patients
ABBV-295 produced clinically meaningful, dose-dependent weight loss over 12–13 weeks
The interim results of the Phase 3 SUCCESSOR-2 study's safety profile aligned with expectations for both mezigdomide and the combination regimen
The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%
DiaMedica said it plans to launch the trial later in 2026
The company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile
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