pediatric

FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up
FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up
Fierce Pharma
Regeneron
Evkeeza
pediatric
Homozygous Familial Hypercholesterolemia
FDA
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Novartis' Tafinlar/Mekinist combo scores new indication in pediatric brain cancer
Novartis' Tafinlar/Mekinist combo scores new indication in pediatric brain cancer
Endpoints
Novartis
Tafinlar
Mekinist
pediatric
brain cancer
FDA
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Pfizer (PFE) Gets FDA Nod for Bivalent COVID Shot in Young Children
Pfizer (PFE) Gets FDA Nod for Bivalent COVID Shot in Young Children
Yahoo/Zacks.com
Pfizer
BioNTech
FDA
pediatric
COVID-19
bivalent boosters
vaccines
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Pfizer/BioNTech submit FDA application for Omicron-adapted booster for young children
Pfizer/BioNTech submit FDA application for Omicron-adapted booster for young children
PM Live
Pfizer
BioNTech
FDA
COVID-19
boosters
vaccines
pediatric
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Study: Extrapolation used in more than half of pediatric drug labeling changes
Study: Extrapolation used in more than half of pediatric drug labeling changes
RAPS.org
regulatory
pediatric
extrapolation
labeling
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FDA authorizes Moderna, Pfizer updated COVID boosters for 6 months old
FDA authorizes Moderna, Pfizer updated COVID boosters for 6 months old
Yahoo/Reuters
Pfizer
BioNTech
Moderna Therapeutics
FDA
COVID-19
vaccines
infants
pediatric
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Britain's health regulator backs COVID vaccine for infants from six months
Britain's health regulator backs COVID vaccine for infants from six months
Yahoo/Reuters
UK
COVID-19
vaccines
infants
pediatric
Pfizer
BioNTech
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Physician viewpoint: Drug supply chain is still 'dysfunctional, opaque'
Physician viewpoint: Drug supply chain is still 'dysfunctional, opaque'
Beckers Hospital Review
drug shortages
physicians
pediatric
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Abandoned Bayer Drug Shows Preclinical Promise for Childhood Brain Tumors
Abandoned Bayer Drug Shows Preclinical Promise for Childhood Brain Tumors
BioSpace
Bayer
medulloblastoma
brain tumors
pediatric
BAY2402234
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Seagen's highest selling drug snags a label expansion for pediatric cancer patients
Seagen's highest selling drug snags a label expansion for pediatric cancer patients
Endpoints
Seagen
Takeda
Adcetris
Hodgkin's lymphoma
FDA
pediatric
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Putting More Emphasis on Advancing Pediatric Device Innovation
Putting More Emphasis on Advancing Pediatric Device Innovation
Medical Devices and Diagnostics Industry
Medtech
devices
pediatric
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FDA authorizes Moderna and Pfizer-BioNTech Bivalent COVID vaccines for booster doses in younger age groups
FDA authorizes Moderna and Pfizer-BioNTech Bivalent COVID vaccines for booster doses in younger age groups
Pharma Live
FDA
Pfizer
Moderna Therapeutics
BioNTech
vaccines
boosters
bivalent boosters
COVID-19
pediatric
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Dupixent Shows Promise as First Treatment for Childhood EoE
Dupixent Shows Promise as First Treatment for Childhood EoE
BioSpace
Dupixent
Sanofi
Regeneron
pediatric
clinical trials
eosinophilic esophagitis
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Pfizer/BioNTech seek FDA nod for new COVID boosters for children
Pfizer/BioNTech seek FDA nod for new COVID boosters for children
Yahoo/Reuters
Pfizer
BioNTech
COVID-19
FDA
vaccines
pediatric
boosters
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FDA releases draft guidance for protecting children in clinical trials
FDA releases draft guidance for protecting children in clinical trials
Clinical Trials Arena
clinical trials
pediatric
FDA
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Moderna seeks FDA nod for Omicron-targeted COVID shot for adolescents, younger kids
Moderna seeks FDA nod for Omicron-targeted COVID shot for adolescents, younger kids
Yahoo/Reuters
Moderna Therapeutics
COVID-19
FDA
boosters
pediatric
vaccines
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Two CRLs later, FDA endorses drug to prevent hearing loss associated with chemo
Two CRLs later, FDA endorses drug to prevent hearing loss associated with chemo
Endpoints
Fennec Pharma
Pedmark
chemotherapy hearing loss
cancer
pediatric
FDA
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Sanofi, AstraZeneca win EMA support for RSV drug in babies
Sanofi, AstraZeneca win EMA support for RSV drug in babies
BioPharma Dive
AstraZeneca
Beyfortus
RSV
Europe
pediatric
infants
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Sanofi’s asthma therapy shows consistent safety profile in Phase III trial
Sanofi’s asthma therapy shows consistent safety profile in Phase III trial
Clinical Trials Arena
Sanofi
Dupixent
pediatric
clinical trials
severe asthma
asthma
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AbbVie, J&J's Imbruvica wins first pediatric nod, this one for chronic graft-versus-host disease
AbbVie, J&J's Imbruvica wins first pediatric nod, this one for chronic graft-versus-host disease
Fierce Pharma
JNJ
AbbVie
Imbruvica
graft vs host disease
pediatric
FDA
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