Post hoc data show cariprazine improved both manic and depressive symptoms through 52 weeks in youth aged 10 to 17 years with bipolar I disorder.
News|Articles|February 28, 2025
FDA news in pediatrics: February 2025
Author(s)Joshua Fitch, Senior Editor
A look back at the FDA submissions and regulatory decisions in the pediatric health care space from February 2025.
Advertisement
Advertisement
As you continue to provide the best care possible for your patients, staying up to date on the quick-hitting headlines and larger key developments from the FDA can be challenging.
Related to this article
Find out the 4 FDA decisions to watch in November 2026 for pediatric care.
Cenobamate sNDAs target PGTC seizures in patients ≥12 years and pediatric focal seizures; phase 3 PGTC data showed a 71.9% median reduction.
FDA approved Lupin's generic of Firdapse for LEMS in patients 6 years and older, but a patent settlement delays US marketing until at least 2035.
A recap of the top pediatric clinical trial results and pipeline data readouts during October 2026.
A recap of the top FDA approvals, regulatory decisions, and pipeline updates affecting pediatric care during October 2026.
In PROGRESS Cohort 2, zilurgisertib reduced total HO volume vs placebo at 24 weeks in children aged 6 to 11 with FOP, with no new HO lesions.
Registry data presented at ASN Kidney Week 2026 linked SCD-PED to higher 90-day survival vs historical controls in pediatric sepsis-associated AKI.
Advertisement
Advertisement