Mesoblast Receives Complete Response From FDA For Biologics License Application For Steroid-Refractory Acute Graft Versus Host Disease In Children
Portfolio Pulse from Benzinga Newsdesk
Mesoblast has received a complete response from the FDA for its Biologics License Application for steroid-refractory acute graft versus host disease in children. The FDA has requested additional information to complete the review of the application.
August 04, 2023 | 2:51 pm
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Mesoblast's application for a Biologics License has received a complete response from the FDA, which has requested additional information. This could potentially delay the approval process.
The FDA's request for additional information indicates that there may be concerns or questions about the application. This could potentially delay the approval process, which could negatively impact Mesoblast's stock price in the short term.
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