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
ABBV-295 produced clinically meaningful, dose-dependent weight loss over 12–13 weeks
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 company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies
The company will address the observations and respond to the U.S. FDA within the stipulated timeframe
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
DiaMedica said it plans to launch the trial later in 2026
The company announced positive topline data from the Phase II ZUPREME-1 trial
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