The validations confirm the completion of the applications and commence the scientific review process
Acquisition of exclusive commercialization rights for European markets
Investigational cell therapy bemdaneprocel continues to be well tolerated with no major safety issues in all 12 participants in low and high dose cohorts through 18 months
The acquisition will build on AstraZeneca’s expertise in respiratory syncytial virus
The acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting antithymic stromal lymphopoietin (TSLP) monoclonal antibody
Submission to be reviewed under FDA real-time oncology review and Project Orbis
The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union
Approval based on a separate phase III trial among Chinese patients reinforcing mepolizumab’s efficacy and safety data
Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway
US FDA approval based on NEURO-TTRansform Phase III results
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