Pediatric brand name

FDA Urges Enhanced Authority to Combat Pediatric and Neonatal Medical Device Shortages

3 months ago talkbio0Tagged Authority, Infant, Newborn, Medical Device Shortages, Pediatric brand name, regulatory, Supply Chain Vulnerabilities, United States Food and Drug Administration

FDA, Medical Device Shortages, Pediatric Patients, Neonatal Patients, Supply Chain Vulnerabilities, Regulatory Authority

Sanofi and SK Bioscience Enhance Partnership for Next-Generation Pneumococcal Conjugate Vaccines

4 months ago talkbio0Tagged Adult, Bioscience, DKK1 gene, next-generation, PCV21, PCVs, Pediatric brand name, Phase III Testing, pneumococcal conjugate, sanofi, Vaccines

Sanofi, SK Bioscience, Pneumococcal Conjugate Vaccines (PCVs), Next-Generation Vaccines, Pediatric and Adult Populations, Phase III Testing, PCV21

Rhythm Pharmaceuticals Secures Expanded FDA Approval for IMCIVREE to Treat Genetic Obesity in Children as Young as 2 Years Old

4 months ago talkbio0Tagged Approved, Bardet-Biedl Syndrome, Genetic obesity, Imcivree, leptin receptor, human, Obesity, PCSK1 gene, Pediatric brand name, POMC, Rhythm, setmelanotide, United States Food and Drug Administration

Rhythm Pharmaceuticals, IMCIVREE, setmelanotide, FDA approval, genetic obesity, Bardet-Biedl syndrome, POMC, PCSK1, LEPR deficiency, pediatric obesity treatment

Mesoblast Secures FDA Approval for Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric Steroid-Refractory Acute Graft-Versus-Host Disease

4 months ago talkbio0Tagged Approved, Cell Therapy, Mesenchymal Stromal Cell Therapy, Mesoblast, Pediatric brand name, Ryoncil, SR-aGVHD, Steroid-Refractory Acute Graft-Versus-Host Disease, United States Food and Drug Administration

Mesoblast, Ryoncil, FDA Approval, Mesenchymal Stromal Cell Therapy, Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD), Pediatric Patients, Cell Therapy

Zelicapavir Shows Promising Antiviral Effect in Pediatric RSV Study

5 months ago talkbio0Tagged Antiviral Agents, Pediatric brand name, Phase 2 Clinical Trials, Respiratory syncytial virus, Zelicapavir

Zelicapavir, RSV, Antiviral, Pediatric, Phase 2 Study, Respiratory Syncytial Virus

Acadia Generates $100 Million from Pediatric Disease Priority Review Voucher Sale

6 months ago talkbio0Tagged Acadia, Drug Industry, Financial Transactions, Pediatric brand name, Priority Review

Acadia Pharmaceuticals, Pediatric Disease Priority Review Voucher, Pharmaceutical Industry, Financial Transactions

FDA Approves Avadel’s Lumryz for Pediatric Narcolepsy Patients

6 months ago talkbio0Tagged Approved, Avadel, Cataplexy, Daytime Somnolence, Excessive (qualifier value), Excessive Daytime Sleepiness, LUMRYZ, Narcolepsy, Pediatric brand name, sodium oxybate, United States Food and Drug Administration

Avadel Pharmaceuticals, Lumryz, narcolepsy, pediatric patients, FDA approval, sodium oxybate, cataplexy, excessive daytime sleepiness (EDS)

Novo Nordisk’s GLP-1 Agonist Demonstrates Significant BMI Reduction in Children Aged 6-12 in Phase 3 Trial

7 months ago talkbio0Tagged agonists, Body mass index procedure, Glucagon-Like Peptide 1, liraglutide, Nordisk, Obesity, Pediatric brand name, Phase 3 trial, semaglutide

GLP-1 agonists, obesity, weight loss, liraglutide, semaglutide, pediatric obesity, BMI reduction, Novo Nordisk, Phase 3 trial.

Novo Nordisk’s Saxenda Demonstrates Significant Weight Loss in Children Aged 6-12 in Phase III Trial

7 months ago talkbio0Tagged EASD24, Nordisk, Obesity, Pediatric brand name, Phase 3 Clinical Trials, Saxenda

Saxenda, Novo Nordisk, pediatric obesity, weight loss, Phase III trial, EASD24

FDA Approves Tris Pharma’s Onyda XR, First Liquid Non-Stimulant ADHD Medication for Pediatric Patients ###

11 months ago talkbio0Tagged Approved, Attention deficit hyperactivity disorder, clonidine, Extended Release Suspension, hydrochloride, Liquid medication, LiquiXR, Non-stimulant, Onyda, Pediatric brand name, Svalbard, Technology, Tris Pharma, United States Food and Drug Administration

Tris Pharma, Onyda XR, ADHD, Non-stimulant, Liquid medication, Pediatric patients, FDA approval, Clonidine hydrochloride, Extended-release oral suspension, LiquiXR technology