Shots: The approval is based on P-II HORIZON study assessing Pepaxto + dexamethasone in 157 patients with r/r MM who have received at least prior 4L of therapy and whose […]readmore
Tags : approval
Shots: The FDA has approved Nulibry based on three clinical trials compared to data from a natural history study in patients with MoCD Type A The results from three clinical […]readmore
Shots: The US FDA has approved the acetaminophen injection available in multiple doses. The company has used dual-sourced API to reduce potential supply risks Acetaminophen injection is available in flexible […]readmore
Shots: The approval is based on ESSENCE trial assessing Amondys 45 vs PBO in patients with DMD with a confirmed mutation amenable to exon 45 skipping. The study is expected […]readmore
Shots: The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to sev. UC The study demonstrated […]readmore
Shots: Health Canada has approved Dupixent for the treatment of mod. to sev. AD in children aged 6 to 11yrs. whose disease is not adequately controlled with topical prescription therapies […]readmore
Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC […]readmore
Shots: The approval is based on P-III PARAGON-HF study involves assessing of Entresto (sacubitril/valsartan) in the treatment of patients with preserved ejection fraction HFpEF The expanded indication enables potential treatment […]readmore
Shots: The approval is based on P-III MEDALIST study involves assessing ReblozyL vs PBO in a ratio (2:1) in adult patients with very low- to intermediate-risk MDS-RS requiring regular RBC […]readmore
Shots: The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat multiple chronic inflammatory diseases The […]readmore