Shots: The approval is based on the P-III REACH3 study evaluates the safety & efficacy of Jakafi vs BAT in patients ≥12yrs. with steroid-refractory chronic GVHD after the failure of […]readmore
Tags : approval
Shots: The US FDA has approved Abbott’s Epic Plus & Epic Plus Supra Stented Tissue valves to treat patients with aortic or MV disease who undergoes valve replacement surgery. The […]readmore
Shots: The approval is based on the TRuE-AD clinical trial program which consists of two P-III studies i.e., TRuE-AD1 & 2 evaluating the safety and efficacy of Opzelura cream (1.5%, […]readmore
Biosimilars
Regulatory
Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receives the US
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis […]readmore
Shots: The approval is based on P-III COSMIC-311 evaluating Cabometyx (60mg, qd) vs PBO in a ratio (2:1) in 258 patients aged ≥12yrs. with radioactive iodine-refractory DTC who progressed after […]readmore
Shots: The approval is based on the P-I/II trial evaluating Exkivity (160 mg) in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior Pt-based therapy The results demonstrated ORR […]readmore
Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C mutation-positive advanced NSCLC whose disease […]readmore
Shots: The approval is based on the P-III STOP 301 trial evaluates Trudhesa (0.725 mg/spray) in 5650+ patients with migraine with or without aura for 24 or 52 wks. The […]readmore
Shots: The approval is based on a RELIANCE study that evaluates efficacy & safety of relma-cel in 59 patients with r/r LBCL who had failed at least 2L of therapy, […]readmore
Shots: The approval is based on the P-III trial that evaluates Ultomiris (q4w/q8w) vs Soliris in children & adolescents aged ≤18yrs. with PNH The interim result showed that the therapy […]readmore