Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
ART-123 is a recombinant human thrombomodulin approved in Japan in 2008
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
For people with relapsed or refractory diffuse large B-cell lymphoma
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
Ukrainian marketing approvals for paclitaxel, oxaliplatin and irinotecan mark a significant milestone in the company’s global expansion strategy
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