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
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 approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
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
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
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
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
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