Shots: The P-III REMDACTA study involves assessing Actemra/RoActemra (tocilizumab) + Veklury (remdesivir) vs PBO + Veklury in hospitalized patients with severe COVID-19 pneumonia receiving SOC The study did not meet […]readmore
Tags : patients
Regulatory
Corium’s Azstarys (serdexmethylphenidate and dexmethylphenidate) Receives the US FDA’s Approval
Shots: The approval is based on a P-III study that involves assessing Azstarys (qd) vs PBO in 150 children aged 6-12yrs. with ADHD The study showed improvement in 1EPs i.e. […]readmore
Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III […]readmore
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: LYSA-LYSARC to conduct a P-II study to evaluate the safety and efficacy of valemetostat in six cohorts of patients with r/r B-cell lymphoma. The study will include ~140 patients […]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 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 P-II SWOG S1500/PAPMET trial involves assessing cabometyx (60 mg, qd with dose reductions to 40 & 20mg ), crizotinib, and savolitinib vs sunitinib in a ratio (1:1:1:1) for […]readmore
Shots: The P-III TAK-620-303 (SOLSTICE) trial involves assessing TAK-620 (400mg) vs conventional antiviral therapies (IAT) in HCT and SOT recipients in a ratio (2:1) with R/R CMV infection refractory with/ […]readmore
Shots: The approval is based on the P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. with HoFH for 24wks. […]readmore