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Pediatric

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Minitablets: Enhancing Safety and Palatability for Pediatric Medicines
Minitablets

Minitablets: Enhancing Safety and Palatability for Pediatric Medicines

Gus LaBella

Mikart

PAO-09-24-CL-01Aug 30, 2024
Beyond Pills: the Rise of Liquid Suspensions for Complex Formulations
Liquid Suspensions

Beyond Pills: the Rise of Liquid Suspensions for Complex Formulations

Gus LaBella

Mikart

PAO-07-24-CL-04Jul 09, 2024
Pediatric Clinical Trials: Considerations for Enrollment and Retention
Pediatric Clinical Trials

Pediatric Clinical Trials: Considerations for Enrollment and Retention

Susan McCune, M.D.; Anusha Streubel, M.D.; Elizabeth Donahue

PAO-02-24-CL-04Mar 01, 2024
Rare Disease Patients Benefit from Clinical Trial Flexibility
Rare Disease Clinical Trials

Rare Disease Patients Benefit from Clinical Trial Flexibility

Tim Rich; Meredith McCumbee; Francis Jones, Ph.D.

PPD, part of Thermo Fisher Scientific

PAO-02-022-CL-03Mar 12, 2022
The European Medicines Agency (EMA)
COVID-19 Vaccine

EMA Starts Evaluating Use of COVID-19 Vaccine Comirnaty in Young People Aged 12 to 15

The European Medicines Agency (EMA)

PR-M05-21-005-1002May 04, 2021
Novavax
COVID-19 Vaccine

Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine

Novavax

PR-M05-21-001May 03, 2021
U.S. Food & Drug Administration
FDA Approval

FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

U.S. Food & Drug Administration

PR-M06-20-NI-021Jun 16, 2020
Amgen
Positive Results

Amgen Announces Positive Results From Two Phase 3 BLINCYTO® Studies In Pediatric Patients

Amgen

PR-M09-19-NI-056Sep 27, 2019
Pfizer
Vaccine

Pfizer Announces Positive Preliminary Results from a 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate for Disease Prevention in Infants

Pfizer

PR-M09-19-NI-028Sep 11, 2019
U.S. Food & Drug Administration
Pediatric

FDA Approves First of its Kind Device to Treat Pediatric Patients with Progressive Idiopathic Scoliosis

U.S. Food & Drug Administration

PR-M08-19-NI-054Aug 20, 2019
Genentech’s Xofluza Flu Treatment Effective in Children
Influenza

Genentech’s Xofluza Flu Treatment Effective in Children

Emilie Branch

Pharma's Almanac

PAO-M07-19-NI-019Jul 22, 2019
U.S. Food & Drug Administration
Drug Approval

FDA Expands Approval of Treatment for Cystic Fibrosis to Include Patients Ages 6 and Older

U.S. Food & Drug Administration

PR-M06-19-NI-056Jun 27, 2019
FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
Botox

FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity

Nice Insight

PR-M06-19-NI-043Jun 24, 2019
U.S. Food & Drug Administration
FDA Approval

FDA Permits Marketing of First Medical Device for IBS Pain Relief in Adolescent Patients

U.S. Food & Drug Administration

PR-M06-19-NI-012Jun 13, 2019
FDA Approves First Anticoagulant Blood Thinner for Use in Children
FDA Approval

FDA Approves First Anticoagulant Blood Thinner for Use in Children

Pharma's Almanac

PAO-M05-19-NI-028May 29, 2019
Samsung Electronics Co., Ltd.
Pediatric

Samsung Demonstrates Viability of Lower Dose Digital Radiography Algorithm for Pediatric Patients

Samsung Electronics Co., Ltd.

PR-M04-19-NI-076Apr 24, 2019
U.S. Food & Drug Administration
Shortage

FDA Efforts to Mitigate Temporary Shortage of Pediatric Breathing Tubes Due to Recent Closure of Illinois Sterilization Facility

U.S. Food & Drug Administration

PR-M04-19-NI-049Apr 16, 2019
Allergan, plc
FDA Approval

Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients

Allergan, plc

PR-M03-19-NI-054Mar 20, 2019
Astellas
Launch

Astellas Launches PROGRAF® Granules (tacrolimus for oral suspension) in the U.S. for Pediatric Liver, Heart, and Kidney Transplant Patients

Astellas

PR-M03-19-NI-051Mar 19, 2019
AOBiome Therapeutics, Inc.
Clinical Trials

AOBiome Doses First Patient in Phase 1b Clinical Trial of B244 for the Treatment of Pediatric Atopic Dermatitis

AOBiome Therapeutics, Inc.

PR-M03-19-NI-022Mar 08, 2019
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