May 23rd 2023
The newly FDA-approved prescription product delivers nalmefene to the nasal cavity to reverse the effects of opioid overdose.
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).
FDA grants emergency use authorization to Moderna’s COVID-19 booster in pediatric patientsOctober 13th 2022
Moderna has announced that their latest BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, has been granted Emergency Use Authorization by the US Food and Drug Administration.
FDA grants ENA-001 orphan drug designation for Apnea of PrematurityOctober 12th 2022
Eagle Pharmaceuticals and Enalare Therapeutics have announced that their ENA-001 drug for the treatment of Apnea of Prematurity has been granted an Orphan Drug Designation by the US Food and Drug Administration.
Whooping cough vaccine approved for use during third trimesterOctober 7th 2022
The US Food & Drug Administration approved tetanus toxoid, reduced diptheria toxoid and acellular pertussis vaccine, adsorbed [Tdap] (Boostrix, GSK) today for immunization during the third trimester of pregnancy to prevent pertussis—or whooping cough—in infants under 2 months of age.
Pfizer and BioNTech request Emergency Use Authorization for Omicron boosterSeptember 28th 2022
Pfizer and BioNTech have applied to the FDA for Emergency Use Authorization of their Omicron BA.4/BA.5-adapted bivalent vaccine booster for use in pediatric patients aged 3 to 11 years.