Shots: Nucala (mepolizumab) has received Health Canada’s approval as an add-on maintenance therapy for adolescents & children aged ≥6yrs. with SEA The extension of NUCALA’s indication for adolescents and children […]readmore
Tags : Severe Eosinophilic Asthma
Biotech
Regulatory
AstraZeneca’s Fasenra Pen (Pre-Filled Auto-Injector) Receives the US FDA’s Approval
Shots: The US FDA has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector, based on P-III GRECO and P-I AMES study The P-III GRECO study involves assessing […]readmore
Shots: The REALITI-A study involves assessing of Nucala (100mg, SC) in 368 patients with severe eosinophilic asthma, being conducted in a routine care setting, compared to the prior 12mos. The […]readmore
Shots: The US FDA’s approval follows the open-label study evaluating PK/PD and long-term safety of Nucala (40mg, SC) in children with severe eosinophilic asthma aged 6 to 11yrs. The approval […]readmore
Regulatory
GSK’s Nucala (mepolizumab) Receives European Commission Approval for Self-Administration in
Shots: The Nucala has received EMA’s marketing authorization for its new methods of administration i.e, a pre-filled pen and a pre-filled safety syringe with their anticipated launch in Europe in […]readmore
Shots: The BORA P-III trial involves assessing of Fasenra (benralizumab) enrolling patients in ratio (1:1) who have completed one of the two SIROCCO or CALIMA P-III trials, administering Fasenra 30 […]readmore
Shots: The comparison study led to assessing of Nucala (mepolizumab), Fasenra (benralizumab), Cinqair (reslizumab) in patients aged ≥12 yrs with similar blood eosinophil counts for the treatment of severe eosinophilic […]readmore