GAIA and Daiichi Sankyo Europe join forces to launch groundbreaking digital therapeutic for heart health
Germany will be the first launch market
Germany will be the first launch market
The first of four planned modules at the new plant is expected to come online by summer 2026
Huwel’s diagnostic solutions leverage open RT-PCR system
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
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
The company will address the observations and respond to the U.S. FDA within the stipulated timeframe
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
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