Keeping Track: Disappointment For Mesoblast And Aquestive; Opdivo/Yervoy Add Mesothelioma Claim; Pediatric Approvals
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Mesoblast Plans Small Trial After Second CRL For GVHD Cell Therapy
Seeking approval for pediatric patients with acute graft-versus-host disease, Mesoblast gets a second US FDA complete response and now says it will seek to get needed data from a small trial in adults.
Mesoblast Plans Small Trial After Second CRL For GVHD Cell Therapy
Seeking approval for pediatric patients with acute graft-versus-host disease, Mesoblast gets a second US FDA complete response and now says it will seek to get needed data from a small trial in adults.
US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks
Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.