Week in review: FDA approvals and expanded indications


Get caught up with our journal! Review some of the top stories from the Contemporary Pediatrics website over the last week, and catch up on anything you may have missed.

Image Credit: Contemporary Pediatrics

Image Credit: Contemporary Pediatrics

Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, March 25 to Friday, March 29, 2024), and click on each link to read and watch anything you may have missed.

1.) FDA approves IXINITY for treatment of hemophilia B in patients 12 years and under

IXINITY is now approved to treat all patients with the hemophilia B to help control bleeding episodes, as well as reduce the frequency of them.

Click here for the full FDA approval article.

2.) Nipocalimab receives Fast Track Designation to treat FNAIT

The Fast Track Designation will allow the development and review timeline of nipocalimab to accelerate. It is granted to drugs with the potential to treat severe conditions and provide unmet vital medical needs.

Click here for the full article.

3.) FDA expands chronic HBV treatment to patients as young as 6 years

The expanded indication approval of the supplemental New Drug Application was based on week 96 data from the phase 2 clinical "Trial 1092," which compared treatment with tenofovir alafenamide 25 mg to placebo in 18 treatment-naïve and treatment-experienced patients aged 6 to less than 12 years weighing at least 25 kg (Cohort 2, Group 1), according to Gilead Sciences.

Click here for the full article.

4.) Primary care digital innovations in type 1 diabetes

Sally Humphrey, DNP, APRN, CPNP-PC, discusses current technology to treat youth with diabetes. Humphrey highlights continuous glucose monitoring systems (CGMs) and how they have evolved and improved.

Click here to watch the full video.

5.) With the correct research, AI in pediatric cardiology has great potential

Scott Ceresnak, MD, explains ways AI technology could be useful when it comes to pediatric cardiology, though he states "big" research data is needed to generate pediatric specific algorithms.

Click here to watch the full interview.

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