Drug Approval | February 24, 2026
Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy
If approved, DTX401 would be the first treatment to address the disease at its root cause
If approved, DTX401 would be the first treatment to address the disease at its root cause
UBT251 appeared to have a safe and well-tolerated profile consistent with incretin-based therapies
The project entails a total planned capital expenditure of approximately Rs. 500 - 520 crore
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
200+ HR leaders and CXOs convened to discuss workforce health, preventive care, and organisational wellbeing as strategic business priorities
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
Our vision is to position India not just as a consumer of advanced simulation technologies but as a creator and exporter of them
The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns
If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
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