The study hit its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy
BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results
Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity
If approved, DTX401 would be the first treatment to address the disease at its root cause
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission
PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients
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