Weekly review: Several key FDA approvals, new puzzler case, and more

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Get caught up with Contemporary Pediatrics! This list helps you navigate our top stories from the week, all in one place.

Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, February 10, to Friday, February 14, 2025), and click on each link to read and watch anything you may have missed.

FDA approves GSK's meningococcal ABCWY vaccine

On February 14, 2025, the FDA has approved GSK’s meningococcal ABCWY (Penmenvy) vaccine for individuals aged 10 to 25, providing protection against the five most common serogroups of Neisseria meningitidis. The phase 3 trial demonstrated strong immunogenicity, non-inferiority to existing vaccines, and a favorable safety profile. Experts highlight the vaccine’s potential to improve coverage, particularly against MenB, which accounts for over half of invasive meningococcal disease cases in U.S. adolescents and young adults.

Click here for the full approval details.

FDA approves insulin-aspart-szjj as biosimilar for diabetes treatment

On February 14, 2025, the approved insulin-aspart-szjj (Merilog; Sanofi-Aventis) as the first rapid-acting insulin biosimilar to Novolog, offering a new option for glycemic control in adults and children with diabetes. This approval aims to enhance competition and accessibility for insulin users, with the biosimilar available in both pre-filled pen and vial forms. While providing a cost-effective alternative, it carries risks such as hypoglycemia and allergic reactions, requiring careful dosing and monitoring.

Click here for the full approval details.

FDA approves non-invasive risdiplam tablet for spinal muscular atrophy

On February 12, 2025, the FDA approved a 5 mg tablet formulation of risdiplam (Evrysdi) for individuals with spinal muscular atrophy (SMA) aged 2 years and older who weigh more than 44 lbs. The tablet, which can be swallowed whole or dispersed in water, offers a more convenient, non-invasive treatment option while maintaining comparable efficacy to the original oral solution. Genentech expects the new formulation to be available in the coming weeks, further enhancing SMA disease management.

Click here for the full approval details.

A green nail after trauma in an 8-year-old boy

An 8-year-old boy presented to the pediatrician’s office for evaluation of his fingernail. His mother reported that the nail had developed a green discoloration and had begun to detach approximately 1 week prior to the visit. There was no associated pain, swelling, or erythema. One month earlier, the boy’s finger had been slammed in a car door, prompting an x-ray that showed no fractures. The patient is otherwise healthy, plays baseball, and swims daily in the family’s swimming pool. There were no other signs of infection or trauma, and the child had no history of similar occurrences.

What's the diagnosis?

Click here to find out, along with a complete differential diagnosis and additional case details.

FDA grants rezpegaldesleukin fast track to treat moderate, severe atopic dermatitis

The FDA has granted fast track designation to rezpegaldesleukin (Rezpeg) for treating moderate-to-severe atopic dermatitis (AD) in patients aged 12 and older who have inadequate response to topical therapies. Early clinical data suggest significant improvement in disease severity, with ongoing phase 2b trials evaluating its long-term efficacy and maintenance dosing. Nektar Therapeutics anticipates topline results from the REZOLVE-AD study in 2025, aiming to address an unmet need in AD treatment.

Click here for more.

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