Pediatric Medicine
Page 1 • 12 itemsAccess global pediatric medicine market intelligence. Discover drug development, regulatory insights, and investment opportunities for children's health.
Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen in McCune-Albright Syndrome
Atossa Therapeutics gains FDA Rare Pediatric Disease designation for (Z)-endoxifen treating McCune-Albright syndrome, qualifying for Priority Review Voucher.
BioMarin VOXZOGO Shows Long-Term Benefits for Achondroplasia in New Clinical Data at PES 2026
BioMarin presents new VOXZOGO data showing long-term benefits on arm span, bone health and growth in children with achondroplasia at PES 2026 meeting.
Laguna Biotherapeutics Receives FDA Clearance for LGNA-100 Pediatric Leukemia Trial
FDA clears Laguna's IND application for LGNA-100, a novel γδ T cell activator targeting high-risk pediatric leukemias, marking key regulatory milestone.
Apotex Receives FDA Approval for Generic Infuvite Pediatric Injection with 180-Day Exclusivity
Apotex announces FDA approval of generic Infuvite Pediatric Injection with 180-day CGT exclusivity, expanding pediatric vitamin therapy options.
Novartis Coartem Baby Receives WHO Prequalification as First Malaria Treatment for Newborns
WHO prequalifies Novartis Coartem Baby, the first malaria treatment for newborns and young infants, enabling global procurement and access.
BrioHealth Solutions Receives FDA Conditional Approval for Pediatric BrioVAD Heart Device Trial
BrioHealth Solutions gets FDA conditional approval to test BrioVAD System in children with advanced heart failure through the Brio4Kids Trial study.
Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11
Sanofi and Regeneron's Dupixent receives FDA approval as first biologic treatment for children with uncontrolled chronic spontaneous urticaria.
Novo Nordisk's Oral Semaglutide Shows Promise as First GLP-1 Therapy for Children with Type 2 Diabetes
Novo Nordisk's PIONEER TEENS trial demonstrates oral semaglutide significantly reduces blood sugar in children with type 2 diabetes, paving way for regulatory filings.
Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11
Sanofi's Dupixent receives FDA approval as first biologic treatment for chronic spontaneous urticaria in young children, expanding pediatric treatment options.
Dupixent Becomes First Biologic Approved for Children Ages 2-11 with Chronic Spontaneous Urticaria
Sanofi's Dupixent receives FDA approval as first biologic treatment for young children with uncontrolled chronic spontaneous urticaria, expanding pediatric options.
Sanofi's Tzield Approved by FDA for Children as Young as 1 Year to Delay Type 1 Diabetes Progression
FDA expands Tzield approval for children aged 1+ with stage 2 type 1 diabetes, marking first disease-modifying therapy to delay insulin dependence.
FDA Approves Sanofi's Tzield for Children Age 1+ to Delay Type 1 Diabetes Onset
Sanofi's Tzield becomes first disease-modifying therapy approved for children as young as one year old to delay insulin-dependent Type 1 diabetes progression.