Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT before alloHSCT in pediatric patients with high-risk first relapsed B-cell ALL. The findings were published in JAMA […]readmore
Tags : Pediatric Patients
Shots: The approval is based on P-lll COMPACT pivotal study and OLE study assessing Haegarda (C1 Esterase Inhibitor, SC) vs PBO in patients aged ≤17yrs. with symptomatic HAE. Results […]readmore
Shots: The US FDA has accepted the Allergan’s sBLA to expand the BOTOX prescribing information for treating detrusor (bladder muscle) overactivity associated with an underlying neurologic condition in pediatric patients […]readmore
Shots: Gilead will begin enrollment in P-II/III clinical trial assessing the safety, tolerability, PK and efficacy of remdesivir in ~50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents The […]readmore
Shots: The approval is based on P-III study which involves assessing of leuprolide acetate (LA,45 mg) in 64 children with central (gonadotropin-dependent) precocious puberty evaluating its safety and pharmacokinetics The […]readmore
Shots: The approval is based on P-I/II SPRINT study assessing Koselugo (bid) as monothx. in pediatric patients aged ≥2yrs. with NF1-related inoperable PNs. The trial was sponsored by NCI CTEP, […]readmore
Shots: The approval is based on P-III study assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, respectively) vs PBO in 171 patients […]readmore
Shots: The P-II/III study involves assessing olipudase alfa (up to 3mg/kg, IV, q2w) vs PBO in 36 adult patients with ASMD for 52wks. demonstrating reduction in spleen volume (39.5% vs […]readmore
Shots: The EC’s approval is based on P-III CADMUS Jr study assessing Stelara (SC) in 44 pediatric patients with mod. to sev. PsO aged 6–11 yrs. from 9 countries. The […]readmore
Shots: The FDA’s approval is based on P-III study assessing the BOTOX in 300+ pediatric patients aged 2-17yrs. being treated for lower limb spasticity. The study included patients with cerebral […]readmore