Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
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
The alliance directly links VivaMed’s computational drug hypotheses with Syngene’s preclinical development capabilities
The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The agreement ensures BIOEMTECH customers can consistently obtain Ac-225 for preclinical studies
TED?A9 is part of S.Biomedics’ expanding pipeline of stem-cell-based therapies, developed using the company’s proprietary targeted embryonic stem cell differentiation platform
40+ most innovative startups with disruptive contributions across MedTech, Medical Devices, BioPharma, Cell and Gene Therapy, AI and ML, Nutraceuticals, and Biomarkers exhibited their cutting-edge solutions
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