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Drug Pipeline News
FDA approves Odactra for treating pediatric house dust mite-induced allergic rhinitis
January 26, 2023
Odactra (House Dust Mite Allergen Extract; ALK) has received approval from the US Food and Drug Administration for use in patients aged 12 to 17 years with house dust mite-induced allergic rhinitis.
VP-102 resubmitted to FDA for molluscum contagiosum approval
January 25, 2023
After addressing a 2021 CRL, Verrica Pharmaceuticals vies for the agent to become the first drug approved to treat the common skin infection.
FDA grants rare pediatric disease designation to OR-499 for adrenocortical carcinoma
January 25, 2023
Orphagen Pharmaceuticals has announced their drug OR-499 received a rare pediatric disease designation for treating pediatric adrenocortical carcinoma from the US Food and Drug Administration.
Lomitapide shows positive results in treating homozygous familial hypercholesterolemia
January 10, 2023
A phase 3 trial of lomitapide showed safety and efficacy for treating homozygous familial hypercholesterolemia (HoFH) in pediatric patients aged 5 to 17 years.
FDA accepts application for nirsevimab against RSV in infants
January 05, 2023
The US Food Administration has agreed to review an application for nirsevimab (Beyfortus; AstraZeneca and Sanofi) to protect infants against RSV.
FDA approves semaglutide for obesity in adolescents
January 03, 2023
Novo Nordisk has announced their product Wegovy received approval from the US Food and Drug Administration for use in adolescents aged 12 years and older with obesity.
Arcutis submits roflumilast cream for treating plaque psoriasis in patients aged 2 to 11 years
December 19, 2022
Arcutis Biotherapeutics, Inc has submitted a supplemental New Drug Application for roflumilast cream (ZORYVE) to the US Food and Drug Administration for treatment of plaque psoriasis in children aged 2 to 11 years.
AbbVie submits sNDA for linaclotide for functional constipation in children and adolescents
December 16, 2022
If approved, according to AbbVie, linaclotide would be the first prescription therapy for FC in this patient population.
FDA approves atezolizumab for alveolar soft part sarcoma in pediatric patients
December 15, 2022
The FDA has approved atezolizumab for use in patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.
Empagliflozin shows positive results in phase 3 trial for children with type 2 diabetes
December 09, 2022
Boehringer Ingelheim and Eli Lilly have announced positive results from a phase 3 trial for Jardiance in reducing blood sugar levels in children with type 2 diabetes.