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
These approvals mark significant progress for Venus Remedies in expanding its market presence
Venus Remedies' oncology wing has also secured marketing authorisation from Myanmar for another chemotherapy drug
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
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