BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
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
Expansion at the Oss (NL) site adds capacity and R&D capabilities, supporting the development and manufacturing of ADCs and other novel bioconjugates from First-in-Human to commercialization
The agreement will see the two companies jointly develop and commercialise premium nutraceutical ingredients in advanced transdermal delivery formats
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options
This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care
Acquisition expands Axol’s portfolio of iPSC-derived retinal organoid and retinal pigment epithelium (RPE) models
Subscribe To Our Newsletter & Stay Updated
