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Pediatric
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Positive Results
Amgen Announces Positive Results From Two Phase 3 BLINCYTO® Studies In Pediatric Patients
PR-M09-19-NI-056
Vaccine
Pfizer Announces Positive Preliminary Results from a 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate for Disease Prevention in Infants
PR-M09-19-NI-028
Pediatric
FDA Approves First of its Kind Device to Treat Pediatric Patients with Progressive Idiopathic Scoliosis
PR-M08-19-NI-054
Influenza
Genentech’s Xofluza Flu Treatment Effective in Children
PAO-M07-19-NI-019
Drug Approval
FDA Expands Approval of Treatment for Cystic Fibrosis to Include Patients Ages 6 and Older
PR-M06-19-NI-056
Botox
FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
PR-M06-19-NI-043
FDA Approval
FDA Permits Marketing of First Medical Device for IBS Pain Relief in Adolescent Patients
PR-M06-19-NI-012
FDA Approval
FDA Approves First Anticoagulant Blood Thinner for Use in Children
PAO-M05-19-NI-028
Pediatric
Samsung Demonstrates Viability of Lower Dose Digital Radiography Algorithm for Pediatric Patients
PR-M04-19-NI-076
Shortage
FDA Efforts to Mitigate Temporary Shortage of Pediatric Breathing Tubes Due to Recent Closure of Illinois Sterilization Facility
PR-M04-19-NI-049
FDA Approval
Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients
PR-M03-19-NI-054
Launch
Astellas Launches PROGRAF® Granules (tacrolimus for oral suspension) in the U.S. for Pediatric Liver, Heart, and Kidney Transplant Patients
PR-M03-19-NI-051
Clinical Trials
AOBiome Doses First Patient in Phase 1b Clinical Trial of B244 for the Treatment of Pediatric Atopic Dermatitis
PR-M03-19-NI-022
Pediatric
Novo Nordisk Files for a Label Update for Fiasp® to the EMA and the FDA Seeking Approval for Use in Children and Adolescents
PR-M03-19-NI-007
Pediatric
American Diabetes Association® Issues Position Statement on Comprehensive Care of Pediatric Patients with Type 2 Diabetes
PR-M11-18-NI-051
Pediatric
Eisai Announces FDA Approval Of FYCOMPA® in Pediatric Patients As Young As 4 Years Old For The Treatment Of Partial-Onset Seizures
PR-M10-18-NI-022
FDA Approval
Sandoz Inc. Announces US FDA Approval of Pediatric Dose of SYMJEPI™ (Epinephrine)
PR-M10-18-NI-007
Pediatric
Incorrect Dosing Cup Leads to Recall of Children’s Advil Suspension
PAO-M09-18-NI-005
Drug Delivery
Automated Insulin Delivery System Approved for Use by More Pediatric Patients
PAO-M06-18-NI-023
Fast Track
Biostage awarded SBIR Fast-Track grant to develop Cellspan™ Esophageal Implant (CEI) as a novel treatment for esophageal atresia in pediatric patients
PR-M04-18-NI-002
