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Latest From Mesoblast Limited
Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
FDA’s Cell, Gene Therapy Office Head Wilson Bryan Set To Retire
OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.
US FDA Again Asked To Hold Off On Approval Of Ryoncil Pediatric Cell Therapy
Attorney says new information Mesoblast submitted following ‘complete response’ letter does not include data from randomized controlled trial, which he says is needed to provide substantial evidence of efficacy in treatment of children with graft-versus-host disease.
US FDA’s ODAC: The Advisory Committee That Can Only Say ‘No’
It has been more than two years since a sponsor went before the Oncologic Drugs Advisory Committee and won a favorable vote on approval of a new drug application. Can FDA really expect an advisory committee to keep saying ‘no’ all the time?
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