Shots: The MAA is based on the ongoing P-II/III CAPELLA study evaluates the antiviral activity of lenacapavir (PO, SC, every 6mos.) in combination with other antiretroviral agents vs PBO in […]readmore
Tags : Validation
Shots: The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) or Opdivo (nivolumab) + CT vs CT […]readmore
Shots: The MAA validation is based on P-II DESTINY-Breast01 trial assessing Trastuzumab Deruxtecan as a monothx in patients with 2L+ HER2 positive metastatic breast cancer and the results were published […]readmore
Shots: The EMA has validated the type II variation application for Bavencio which is based on P-III JAVELIN Bladder 100 study assessing Bavencio +BSC vs BSC as monothx. in 700 […]readmore
Shots: The MAA of ide-cel is based on P-II KarMMa study assessing ide-cel in heavily pre-treated 140 patients with r/r MM, prior treated with at least 3 therapies including an […]readmore
Shots: The MAA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with MCL whose diseases is refractory & relapsed following up to five prior therapies […]readmore
Shots: The BLA and MAA are based on P-III CEDAR and SEQUOIA studies assessing Abicipar (quarterly dosing regimen) vs ranibizumab in patients with neovascular (wet) age-related macular degeneration resulting in […]readmore
Shots: The MAA is based on P-III FINCH studies assessing Filgotinib (qd) in patients with RA resulted in improvements in clinical signs & symptoms, low disease activity and remission, inhibition […]readmore
Shots: The Validation study involves assessing of MSProDiscuss in 198 patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or a suspected transition to SPMS across the US, Canada & […]readmore