Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA
Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options
The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
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