Most Recent Articles by Diana Ernst
Unlike other generic approvals, epinephrine auto-injectors are considered "combination products" because they consist of both a drug and a device, making the approval process more challenging.
The authors write that once severe asthma is diagnosed, clinicians should determine asthma endotype (Type2-high or Type2-low) to help choose the best therapy for the patient.
The approval was based on data from a 24-week, open-label, Phase 3 study in patients aged 2 to 5 years.
The approval was based on data from a randomized, single-blind, multicenter, dose-ranging, crossover study which evaluated the safety and efficacy of Cinryze in 12 pediatric patients (7 to 11 years old).
Continuous positive airway pressure (CPAP) remains the mainstay of medical treatment for OSA.