Drug Approval | March 10, 2026
FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
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
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%
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations
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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