Shots: The approval was based on a P-I/II ZUMA-3 study assessing Tecartus in adult patients aged ≥18yrs. with ALL whose disease is refractory to or has relapsed following first standard […]readmore
Tags : approval
Shots: The US FDA has granted premarket approval of TransMedics’s OCS liver system for use with organs from DBD and DCD. The approval is based on the results of the […]readmore
Shots: The company has received CE Mark for its radial artery access portfolio including Rist 079 radial access guide catheter and Rist radial access selective catheter to treat patients with […]readmore
Shots: The approval is based on the ICONIC study as well as 5yrs. of data from supportive studies that evaluate Livmarli in 86 patients with ALGS The results from the […]readmore
Shots: The approval was based on a clinical program including P-III ADVANCE study, P-IIb/III study & P-III LTS study evaluated the safety, efficacy & tolerability of Qulipta (PO, 10/30/60mg) vs […]readmore
Shots: The approval is based on P-III BEACON CRC trial evaluating Braftovi (300mg, qd) + Erbitux vs irinotecan + Erbitux or Folfiri + Erbitux in a ratio (1:1:1) in 441 […]readmore
Shots: The approval was based on the clinical program including two P-III TULIP & P-II MUSE trials evaluated the efficacy and safety of Saphnelo vs PBO in 362 & 305 […]readmore
Biosimilars
Regulatory
Apobiologix’s Bambevi (biosimilar, bevacizumab) Receives Health Canada Approval for Multiple
Shots: Apobiologix expands its footprints in Canada with the approval of Bambevi + CT to treat colorectal, lung, brain and ovarian cancer The approval is coupled with well-established Apobiologix supportive […]readmore
Shots: The approval is based on the P-IIIb HAUSER-RCT study evaluating the safety & efficacy of Repatha (420mg, SC) vs PBO in a ratio (2:1) in pediatric patients aged 10 […]readmore
Shots: The NMPA has approved the IND application of SPR206 (IV) for the treatment of MDR gram-negative bacterial infections. Everest will initiate the clinical program in China & results from […]readmore