Drug Pipeline News

The FDA has granted Emergency Use Authorization (EUA) of the JYNNEOS vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.

If approved, ibrexafungerp would be the first and only approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent vulvovaginal candidiasis (RVVC).

This decision by the US Food and Drug Administration marks the first approved treatment for pediatric lupus nephritis.

What we know about monkeypox in pregnancy, including treatment recommendations, vaccination, and postpartum care.

VIVUS LLC announced the US Food and Drug Administration's approval of QSYMIA (phentermine and topiramate extended-release capsules) for the treatment of obesity in adolescents ages 12 to 17 years.

The approval represents an adjunctive therapy option for pediatric patients older than age 16, as well as adults.

If approved, trofinetide has the potential to be a new treatment for Rett syndrome in pediatric and adult patients 2 years and older.

Opzelura (ruxolitinib) cream is the first and only FDA-approved treatment for adult and pediatric patients 12 years of age or older with vitiligo.

Nonstimulant drugs and even nonmedication options are available for use.

Cynthia J. Trickett, PA-C, MPAS, discusses the personal and clinical effects of atopic dermatitis in adult and pediatric patients at the 2022 Maui Dermatology Conference for PAs & NPs.

Ruling comes in cases of physicians serving in prison for convictions over prescription drugs.

Recently, the FDA announced the approval of supplemental indication for phentermine and topiramate extended-release capsules for chronic weight management in children aged 12 years and older.

Entrepreneur beats prices of supply chain wholesalers, PBMs, pharmacies, and insurers.

Data from a recent study of once weekly somapacitan injection shows positive results for prepubertal children with growth hormone deficiency (GHD).

Currently approved for the treatment of vulvovaginal candidiasis, and if the sNDA is approved, ibrexafungerp would be the first and only oral non-azole medication for the prevention of recurrent VVC.

The FDA recently announced the acceptance of a supplemental New Drug Application for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate .5 mg in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

In a video for Contemporary Pediatrics®, Tina Tan, MD, FAAP, FIDSA, FPIDS, discusses an expansion of vaccine access likely to come with the FDA approval of the PRIORIX vaccine.

Verrica received a Complete Response Letter from the FDA regarding their New Drug Application for the topical molluscum contagiosum treatment, VP-102.

Evinacumab phase 3 results show a 48% LDL-C reduction in children with homozygous familial hypercholesterolemia.

A look at what the Contemporary Pediatrics® team covered this week.

Contemporary Pediatrics® Editorial Advisory Board member Donna Hallas shares her thoughts on the recent authorization of a Pfizer-BioNTech COVID-19 booster shot for children 5-11 years old.

Children may receive a single booster shot at least 5 months after completing their initial Pfizer-BioNTech 2-dose series.

Pfizer/BioNTech announce positive results for a third dose of their COVID-19 vaccine for children

Dr. Paller discusses the findings of the clinical trial examining the long-term effects of ixekizumab for treating psoriasis in children.

Editorial board member Donna Hallas, PhD, CPNP, PPCNP-BC, PMHS, FAANP, FAAN, discusses the recently release topline data, the potential timeline, and what potential stumbling blocks could be.

Editor-in-chief Tina Q. Tan, MD, FAAP, FIDSA, FPIDS, discusses how to help parents who are worried or nervous about the delay in the expansion of the Pfizer/BioNTech vaccine to children aged 6 months to younger than 4 years.

The NVX-CoV2373 vaccine was evaluated in adolescents aged 12 to 17 years.

The US Food and Drug Administration has given Priority Review to the supplemental Biologics License Application for the use of Dupixent® as an add-on maintenance treatment for moderate-to-severe dermatitis in children aged 6 months to 5 years.

Abigail Donovan, MD, discusses what brexpiprazole can do for treating schizophrenia in older children.