Shots: The approval is based on a P-III study that evaluates Invega hafyera (q6mos., twice-yearly injectable) vs Invega trinza in 702 adults in a ratio (2:1) aged 18-70yrs. with schizophrenia […]readmore
Tags : approval
Shots: The approval is based on P-III ASPEN trial evaluating Brukinsa (160mg, bid, or 320 mg, qd) vs ibrutinib in 201 patients with WM who harbor an MYD88 mutation The […]readmore
Shots: The approval is based on the P-III heiGHt trial evaluating Skytrofa (qw) vs somatropin in 161 treatment-naïve children ≥aged 1yrs. with GHD who have growth failure due to inadequate […]readmore
Shots: The conditional approval is based on the P-II L-MIND study evaluating the safety and efficacy of tafasitamab + lenalidomide in patients with r/r DLBCL who are not eligible for […]readmore
Shots: The FDA has approved the Oncomine Dx target test as a CDx to identify patients with IDH1 mutated CCA who may be candidates for Servier’s Tibsovo Oncomine Dx Target […]readmore
Shots: The approval is based on 3 P-III studies i.e., Measure Up 1/2/AD Up evaluating the efficacy & safety of Rinvoq (15/30 mg, qd) as monothx. with TCS vs PBO […]readmore
Shots: The approval is based on 3 P-III studies i.e., BE VIVID, BE READY, BE SURE evaluating the efficacy & safety of bimekizumab vs PBO + ustekinumab, PBO, adalimumab in […]readmore
Shots: The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose The vaccine […]readmore
Biosimilars
Regulatory
Samsung Bioepis’ Byooviz (biosimilar, ranibizumab) Receives EC’s Approval for the
Shots: The EC has approved Byooviz (biosimilar, ranibizumab) in the EU for the treatment of Ophthalmic disease Lucentis is used to treat ophthalmic disease & macular degeneration. Byooviz marks the […]readmore
Shots: The FDA has approved the Ventana MMR RxDx Panel test as a CDx to identify patients with dMMR advanced solid tumors, who may be eligible for Jemperli monothx., based […]readmore