That is a very interesting point and one I believe has caused and is continuing to causing confusion.
The company on approval 19/12/2024 announced that:
RYONCIL is the first FDA-approved therapy for children aged 2 months and older, includingadolescents and teenagers
This is slightly different to the FDA announcement 18/12/2024 :
On December 18, 2024, the Food and Drug Administration approved remestemcel-L-rknd (Ryoncil, Mesoblast, Inc.), an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older.
In the FDA Pediatric Drug Development: RegulatoryConsiderations — they define pediatric for "drug developement" :
For purposes of pediatric drug development, FDA generally considers the pediatric population to include those patients from birth to younger than 17 years (i.e., birth through 16 years of age),and to include the subpopulation age groups of neonates, infants, children, and adolescents.
What is confusing is that pediatric for Medical Devices is defined as:
Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21
I noticed it and researched it, when @Phaedrus (quite correctly) stated that Ryoncil was approved for use in children up to 16 years old and under 17 yo (I had previously and incorrectly been under the impression that pediatrics included the years up to 21 yo.
The difference is devices vs drugs
MSB Price at posting:
$1.78 Sentiment: Buy Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)