Drug Approval | March 13, 2026
Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Marks significant milestone for breakthrough biologic to treat rare blood cancers
Marks significant milestone for breakthrough biologic to treat rare blood cancers
The approval comes after a systematic review of published literature
The company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies
Strong performances in its Life Science, Healthcare and Electronics divisions — particularly Process Solutions, Cardiovascular treatments and Semiconductor Materials — powered the company’s results
The system also introduces Imaging Scanner Interface 2 (ISI2) capability, enabling direct communication between injector and scanner to improve exam coordination and operational efficiency
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
AA, a chronic immune disease, can cause extensive and unpredictable hair loss
Arcellx develops innovative immunotherapies for cancer and other incurable diseases
The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration
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
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