Mesoblast Gets FDA's Special Pediatric Designation for Revascor Heart Treatment
19 January 2024 - 11:28AM
Dow Jones News
By Dean Seal
Mesoblast said regulators have granted their rare pediatric
disease designation to its cell therapy Revascor for children with
hypoplastic left heart syndrome.
The Australian biopharmaceutical company said Thursday that the
special status from the Food and Drug Administration is granted for
serious or life-threatening diseases that primarily affect
children.
If the biologics licensing application for Revascor is approved,
Mesoblast may now be eligible to receive a priority-review voucher
from the FDA that can be used on any subsequent marketing
application or transferred to a third party, the company said.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
January 18, 2024 19:13 ET (00:13 GMT)
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