pediatric

FDA advisers recommend approval of monoclonal antibody to protect newborns and young children from RSV
Stat
Thu, 06/8/23 - 09:47 pm
AstraZeneca
RSV
FDA
monoclonal antibodies
pediatric
Beyfortus
New FDA Guidance Aims to Increase Number of Children in Clinical Trials
BioSpace
Fri, 05/19/23 - 10:11 am
FDA
pediatric
clinical trials
SiSaf gets green light from FDA for osteopetrosis treatment
Biopharma Reporter
Mon, 05/15/23 - 10:16 am
SiSaf
orphan drugs
pediatric
FDA
osteopetrosis
SIS-101-ADO
Pfizer wins FDA nod for Prevnar 20 pneumonia vaccine in children
Seeking Alpha
Thu, 04/27/23 - 10:56 pm
Pfizer
vaccines
FDA
Prevnar 20
pneumococcal disease
pediatric
FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up
Fierce Pharma
Wed, 03/22/23 - 11:14 am
Regeneron
Evkeeza
pediatric
Homozygous Familial Hypercholesterolemia
FDA
Novartis' Tafinlar/Mekinist combo scores new indication in pediatric brain cancer
Endpoints
Sun, 03/19/23 - 01:36 pm
Novartis
Tafinlar
Mekinist
pediatric
brain cancer
FDA
Pfizer (PFE) Gets FDA Nod for Bivalent COVID Shot in Young Children
Yahoo/Zacks.com
Thu, 03/16/23 - 09:25 am
Pfizer
BioNTech
FDA
pediatric
COVID-19
bivalent boosters
vaccines
Pfizer/BioNTech submit FDA application for Omicron-adapted booster for young children
PM Live
Thu, 03/2/23 - 10:01 am
Pfizer
BioNTech
FDA
COVID-19
boosters
vaccines
pediatric
Study: Extrapolation used in more than half of pediatric drug labeling changes
RAPS.org
Wed, 02/15/23 - 10:50 am
regulatory
pediatric
extrapolation
labeling
FDA authorizes Moderna, Pfizer updated COVID boosters for 6 months old
Yahoo/Reuters
Thu, 12/8/22 - 10:06 am
Pfizer
BioNTech
Moderna Therapeutics
FDA
COVID-19
vaccines
infants
pediatric
Britain's health regulator backs COVID vaccine for infants from six months
Yahoo/Reuters
Tue, 12/6/22 - 10:27 am
UK
COVID-19
vaccines
infants
pediatric
Pfizer
BioNTech
Physician viewpoint: Drug supply chain is still 'dysfunctional, opaque'
Beckers Hospital Review
Wed, 11/30/22 - 10:54 am
drug shortages
physicians
pediatric
Abandoned Bayer Drug Shows Preclinical Promise for Childhood Brain Tumors
BioSpace
Thu, 11/17/22 - 11:48 am
Bayer
medulloblastoma
brain tumors
pediatric
BAY2402234
Seagen's highest selling drug snags a label expansion for pediatric cancer patients
Endpoints
Sun, 11/13/22 - 07:01 pm
Seagen
Takeda
Adcetris
Hodgkin's lymphoma
FDA
pediatric
Putting More Emphasis on Advancing Pediatric Device Innovation
Medical Devices and Diagnostics Industry
Mon, 11/7/22 - 05:22 pm
Medtech
devices
pediatric
FDA authorizes Moderna and Pfizer-BioNTech Bivalent COVID vaccines for booster doses in younger age groups
Pharma Live
Wed, 10/12/22 - 10:36 am
FDA
Pfizer
Moderna Therapeutics
BioNTech
vaccines
boosters
bivalent boosters
COVID-19
pediatric
Dupixent Shows Promise as First Treatment for Childhood EoE
BioSpace
Wed, 10/12/22 - 10:33 am
Dupixent
Sanofi
Regeneron
pediatric
clinical trials
eosinophilic esophagitis
Pfizer/BioNTech seek FDA nod for new COVID boosters for children
Yahoo/Reuters
Mon, 09/26/22 - 10:39 am
Pfizer
BioNTech
COVID-19
FDA
vaccines
pediatric
boosters
FDA releases draft guidance for protecting children in clinical trials
Clinical Trials Arena
Mon, 09/26/22 - 10:35 am
clinical trials
pediatric
FDA
Moderna seeks FDA nod for Omicron-targeted COVID shot for adolescents, younger kids
Yahoo/Reuters
Sun, 09/25/22 - 02:31 pm
Moderna Therapeutics
COVID-19
FDA
boosters
pediatric
vaccines

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