Top pediatric FDA approvals of 2025

We've officially turned the calendar to 2026... Happy New Year from Contemporary Pediatrics!

Let's take a look back at some of the top pediatric FDA approvals from 2025.

Editor’s note:

Each year, the FDA approves several treatments across various indications and patient populations, with every approval important for that population. There are no true “top” approvals when it comes to the better care and treatment of pediatric patients across the entire spectrum of health care. The highlighted list below of FDA approvals that took place in 2025 is based on editorial discussions with pediatric health care experts, the novelty of the treatments, and the expected impact on the disease states.

FDA approves GSK's meningococcal ABCWY vaccine

On February 15, 2025, the FDA approved meningococcal ABCWY (MenABCWY, Penmenvy; GSK) vaccine for use in individuals aged 10 to 25 years. The vaccine targets 5 groups of the bacteria Neisseria meningitidis (A,B,C,W, AND Y) that cause the most invasive meningococcal disease cases (IMD) globally. The vaccine combines antigenic components of the meningococcal group B vaccine (Bexsero) and meningococcal groups A, C, Y, and W-135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (Menveo).

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FDA approves neffy 1 mg for anaphylaxis in children aged 4 years and older

As of March 5, 2025, epinephrine nasal spray (neffy; ARS Pharmaceuticals) 1 mg is FDA approved to treat type I allergic reactions, including anaphylaxis, in children aged 4 years and older who weigh 33 to 66 lbs.

With the approval, neffy becomes the first and only needle-free epinephrine treatment indicated for younger children. The expanded indication into a younger population comes after the August 9, 2024, initial approval of neffy for adults and pediatric patients who weigh at least 66 lbs.

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FDA approves gepotidacin for uncomplicated UTI treatment in females 12 years and up

On March 25, 2025, the FDA approved gepotidacin (Blujepa; GSK), for use in treating uncomplicated urinary tract infections (uUTIs) in female patients aged at least 12 years and weighing at least 40 kg.

"I think the value [of gepotidacin] for uncomplicated UTIs is still really high. Because we have therapies that we can utilize, such as nitrofurantoin or fluoroquinolones, but at the same time, we've utilized those for a little while, and so individuals' antibiograms might show some type of resistance," said Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of pharmacy at Emory Healthcare and Winship Cancer Institute at the time of approval.

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FDA approves dupilumab for chronic spontaneous urticaria in ages 12 and up

On April 18, 2025, the FDA approved a resubmitted supplemental biologics license application (sBLA) for dupilumab (Dupixent; Regeneron and Sanofi) to treat chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older. The interleukin (IL)-4 and IL-13 inhibitor for this CSU indication is designed to treat those whose disease is not adequately controlled with H1 antihistamine treatment, and is the first targeted therapy for CSU in over a decade.

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FDA approves pz-cel for recessive dystrophic epidermolysis bullosa

On April 25, 2025, the FDA approved prademagene zamikeracel (Zevaskyn; Abeona Therapeutics) (pz-cel), as the first and only autologous, gene-modified cell therapy for adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Pz-cel became the first FDA-approved product designed to treat chronic RDEB wounds with a single application. RDEB is a rare and debilitating genetic skin disorder caused by mutations in the COL7A1 gene, leading to fragile skin that blisters and wounds easily.

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FDA approves roflumilast foam 0.3% for scalp, body psoriasis

On May 22, 2025, the FDA approved roflumilast (Zoryve; Arcutis Biotherapeutics) topical foam 0.3% to treat plaque psoriasis of the scalp and body in patients aged 12 years and older.

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FDA approves MenQuadfi meningococcal vaccine for children 6 weeks or older

On May 23, 2025, the FDA approved an expanded indication of Sanofi's quadrivalent meningococcal vaccine MenQuadfi—for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W, and Y—to include children aged 6 weeks to 23 months. MenQuadfi was first approved by the FDA on April 23, 2020, for individuals aged 2 years and older, based on results from 5 double-blind, randomized, multicenter phase 2 and 3 trials.

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FDA approves clesrovimab to protect infants during first RSV season

On June 9, 2025, the FDA approved Merck's monoclonal antibody clesrovimab (Enflonsia) to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.

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FDA approves twice-yearly lenacapavir as PrEP for HIV in adolescents, adults

On June 18, 2025, the FDA approved Gilead Sciences' lenacapavir (Yeztugo), an injectable HIV-1 capsid inhibitor, indicated as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who weigh at least 35 kg (77.16 lbs).

With the federal agency's decision, lenacapavir becomes the first and only twice-yearly option available in the United States for those who need or want PrEP.

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FDA approves gepotidacin as oral treatment for urogenital gonorrhea

On December 11, 2025, the FDA approved the supplemental new drug application (sNDA) for gepotidacin (Blujepa; GSK) as an oral treatment option for uncomplicated urogenital gonorrhea 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. The approval provides a noninjectable alternative to existing standard therapy for this sexually transmitted infection.

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FDA approves Nuzolvence (zoliflodacin) for treatment of uncomplicated urogenital gonorrhea in 12 years and up

On December 12, 2025, the FDA approved Nuzolvence (zoliflodacin; Innoviva Specialty Therapeutics), a new, single-dose oral treatment indicated for uncomplicated urogenital gonorrhea in adults and children 12 years and older who weigh at least 77 pounds. The product is administered as a single oral dose and represents 1 of 2 newly approved treatment options for uncomplicated urogenital gonorrhea in nearly 2 decades.

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