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
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
200+ HR leaders and CXOs convened to discuss workforce health, preventive care, and organisational wellbeing as strategic business priorities
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
Fid?s brings core strengths across imaging applications and human biology, supporting work in digestive disease, GI oncology, and select solid tumors
Pangea will use its integrated validation platform and regulatory expertise to oversee analytical and clinical validation of Gene Solutions’ multi-omics technologies.
The company has posted net profit of Rs. 4,064.9 crore for the 9 months period ended December 31, 2025
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