Dupixent Asthma Indication Expanded to Include Younger Patients
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
Pediatrics
Digital Therapeutic Approved for Vision Improvement in Children With Amblyopia
With Luminopia One, patients watch therapeutically modified TV shows and movies to improve their vision within a virtual reality headset.
Flucelvax Quadrivalent Approval Expanded to Include Younger Patients
The expanded approval was based on data from a phase 3 study that compared Flucelvax Quadrivalent to a US-licensed comparator quadrivalent influenza vaccine.
Skytrofa, a Once-Weekly Therapy for Pediatric Growth Hormone Deficiency, Now Available
The approval was based on data from the phase 3 heiGHt trial, which compared Skytrofa to somatropin in 161 treatment-naïve, prepubertal patients with growth hormone deficiency.
Pfizer-BioNTech Submit Request for Emergency Use of Pediatric COVID-19 Vaccine
The Companies recently submitted data from a phase 2/3 trial that included 2268 pediatric participants.
Livmarli Approved for Cholestatic Pruritus in Alagille Syndrome
The approval was based on data from the phase 2b ICONIC study, along with 5 years of data from supportive studies.
Study Shows Similar Safety Profile With Rivaroxaban vs ASA After Fontan Procedure
The phase 3 UNIVERSE study evaluated rivaroxaban oral suspension in patients aged 2 to 8 years with single ventricle physiology who had the Fontan procedure.
Survey Shows High Level of Parental Hesitancy for COVID-19 Vaccines
The survey asked about the likelihood of both child and parental vaccination, perceptions about the vaccines and the level of trust in various sources of information.
Lexette Approval Expanded to Include Adolescents with Plaque Psoriasis
The expanded approval was based on data from adequate and well-controlled phase 3 studies as well as an open-label safety study in adolescents.
Lower Dose COVID-19 Vaccine Appears Safe, Immunogenic in Children 5 to 11 Years Old
Participants 5 to 11 years of age received a 2-dose regimen of 10mcg administered 21 days apart.
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