Shots: The EC has granted MAA which is based on P-III ENVISION study assessing Givlaari (2.5 mg/kg monthly, SC) vs PBO in 94 patients aged ≥12yrs. in a ratio (1:1) […]readmore
Tags : Givlaari
Shots: The CHMP’s positive opinion is based on P-III ENVISION study involves assessing Givlaari (SC, 2.5 mg/kg monthly) in 94 patients aged ≥12yrs. with AHP in a ratio (1:1) across […]readmore
The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA […]readmore
Shots: The US FDA approval is based on P-III ENVISION study assessing Givlaari vs PBO in 94 patients with AHP at 36sites across 18 countries. Givlaari got FDA’s approval in […]readmore