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
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
This multi-year CDMO agreement involves significant, ongoing manufacturing for a global pharmaceutical major
The clinical program has benefited from extensive European Union support, including the IMI2 TRIC-TB and UNITE4TB projects, as well as funding from the EDCTP2 bEto-TB project
Net sales reached CHF 1,327.8 million, up 2.6% year-on-year in Swiss francs, or 4.3% at constant exchange rates
Merck is currently conducting approximately 80 Phase 3 studies, and the company expects more than 20 new growth drivers over next several years, almost all with blockbuster potential
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 NDA filing is supported by results from the phase III evERA Breast Cancer study
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