Contemporary Pediatrics

12/13/2025

In case you missed it:

We highlight reports that the is launching a safety review of preventive measure nirsevimab and clesrovimab.

Read more on these reports, as well as the data that has established both preventive measures as welcomed therapies to prevent RSV-associated lower respiratory tract disease.

MORE: https://hubs.li/Q03Y3t6p0

12/12/2025

Edward Hook, MD, emeritus professor of Medicine, University of Alabama at Birmingham, emphasized the importance of today's zoliflodacin approval to treat for the treatment of uncomplicated urogenital in adults and pediatric patients aged 12 years and older who weigh at least 35 kg.

Watch the full interview: https://www.contemporarypediatrics.com/view/edward-hook-md-reacts-to-the-fda-approval-of-zoliflodacin-for-uncomplicated-urogenital-gonorrhea

12/12/2025

🚨The FDA has approved Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea in adolescents and adults aged 12 years and older.

💊This approval offers pediatricians a new oral treatment option for adolescent patients amid rising concerns about antimicrobial resistance.

👩‍⚕️ Learn more about the data supporting this approval.
https://hubs.li/Q03Y1dCx0

12/12/2025

NEW FROM THE FDA:

The agency has approved BioCryst Pharmaceuticals, Inc.'s berotralstat ( ) prophylactic oral pellets for pediatric patients aged 2 to

12/12/2025

🆕 New FDA-approved option for Rett syndrome

The FDA has approved DAYBUE STIX, a powder formulation of trofinetide, for adults and children aged 2 years and older.

✔️ Bioequivalent to the oral solution
🥤 Flexible dosing volume and taste options
👩‍⚕️ Expanded formulation choice for clinicians and caregivers

🔗 Learn more: https://hubs.li/Q03X-0YG0

12/12/2025

Phase 3 results show oral zoliflodacin was non-inferior to ceftriaxone and azithromycin for uncomplicated urogenital gonorrhea.

Phase 3 results show oral zoliflodacin was non-inferior to ceftriaxone and azithromycin for uncomplicated urogenital gonorrhea.

12/11/2025

Breaking news:

The federal agency has approved GSK's gepotidacin (Blujepa) as an oral option to treat uncomplicated urogenital in patients aged 12 years and older weighing at least 45 kg, and who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae.

Full details: https://hubs.li/Q03XVysp0

12/11/2025

If you missed it:

The FDA is launching a safety review of preventive monoclonal antibodies and . Reuters reported that FDA officials, appointed under Secretary Robert F. Kennedy, Jr., made inquiries into the RSV preventive therapies in the summer, and that senior FDA adviser Tracy Beth Hoeg began questioning safety in June.

Full details and data associated with approvals of both therapies: https://hubs.li/Q03XT9HP0

12/10/2025

Dr. Angeliki Asimaki, Reader in Cardiac Morphology and Sudden Death from the School of Health and Medical Sciences at City St George’s, University of London, lead researcher of arrhythmogenic cardiomyopathy cheek swab, explains the link between the skin and the heart and why detection via cheek swab has a lot of potential for benefit.

Watch our full interview with Asimaki here: https://www.contemporarypediatrics.com/view/dr-angeliki-asimaki-explains-arrhythmogenic-cardiomyopathy-detection-via-cheek-swab

12/10/2025

🚨The FDA has approved Waskyra, the first cell-based gene therapy for WAS, for patients ≥6 months who lack a matched related donor but are eligible for hematopoietic stem cell transplant.

Evaluation demonstrated significant reductions in infections and bleeding complications and may broaden treatment pathways beyond donor-dependent transplantation.

Read the full clinical details here:
https://hubs.li/Q03XFBrd0

12/09/2025

Parents have questions about aluminum in vaccines—and now pediatricians have a clearer evidence summary to share.

A new Pediatrics review found no systemic safety concerns related to aluminum-adjuvanted vaccines. Decades of use, along with large epidemiologic studies, continue to support aluminum’s safety and importance for durable immune protection in early childhood.

See the full article on Contemporary Pediatrics: https://hubs.li/Q03XthGM0

12/08/2025

New from the :

The agecy has approved Gamida Cell Ltd's omidubicel-onlv (Omisirge) as the first hematopoietic stem cell transplant (HSCT) therapy authorized to treat patients with severe aplastic anemia (SAA).

SAA is a rare and life-threatening disease in which bone marrow fails to produce adequate red blood cells, white blood cells, and platelets.

More on SAA and omidubicel-onlv, including the latest data from the ASH 2025 Annual Meeting: https://hubs.li/Q03Xk-YN0