March 18th 2023
A recent study indicated that lebrikizumab treatment for 16 weeks was effective for adolescents and adults with moderate-to-severe atopic dermatitis.
March 10th 2023
FDA accepts sNDA for empagliflozin in children with type 2 diabetesMarch 8th 2023
A supplemental New Drug Application for empagliflozin (Jardiance; Boehringer Ingelheim and Eli Lilly and Company) in pediatric patients with type 2 diabetes has been accepted by the FDA.
Arcutis submits roflumilast foam 0.3% for FDA approval in seborrheic dermatitisFebruary 23rd 2023
A New Drug Application has been submitted to the FDA for potential approval of roflumilast foam 0.3% for the treatment of seborrheic dermatitis in adults and adolescents.
FDA warns against pediatric use of Hospira’s potassium phosphates drug productFebruary 13th 2023
In a recent statement, the US Food and Drug Administration warned pharmacies and health care providers about unsafe aluminum levels for pediatric patients in Hospira’s unapproved potassium phosphates drug product.
FDA approves lanadelumab for hereditary angioedema in patients aged 2 years and olderFebruary 6th 2023
Lanadelumac (TAKHZYRO; Takeda) has received an approval for a supplemental Biologics License Application to prevent hereditary angioedema attacks in pediatric patients aged 2 years and older.
FDA approves pre-filled tezepelumab pen for severe asthma in adolescentsFebruary 2nd 2023
The US Food and Drug Administration has approved the use of a pre-filled tezepelumab (TEZSPIRE; Amgen and AstraZeneca) pen in patients aged 12 years and older with severe asthma.
FDA approves Odactra for treating pediatric house dust mite-induced allergic rhinitisJanuary 26th 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.
FDA grants rare pediatric disease designation to OR-499 for adrenocortical carcinomaJanuary 25th 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.
Arcutis submits roflumilast cream for treating plaque psoriasis in patients aged 2 to 11 yearsDecember 19th 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.
Empagliflozin shows positive results in phase 3 trial for children with type 2 diabetesDecember 9th 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.
FDA approves teplizumab for delay of type 1 diabetes in patients 8 years and upNovember 18th 2022
The US FDA announced the approval of teplizumab (Tzield), which is administered through IV infusion once daily for 14 consecutive days, for delaying the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.
Roflumilast cream safe, effective for atopic dermatitis in children 6 years and upNovember 16th 2022
Recently announced data from the INTEGUMENT-1 phase 3 clinical trial demonstrated positive safety and efficacy results for atopic dermatitis patients 6 years and older treated with roflumilast cream (Arcutis Biotherapeutics).