Shots: The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients with recurrent, metastatic, or LA […]readmore
Tags : approval
Regulatory
Jazz’s Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Receives the US FDA’s
Shots: The approval is based on clinical data from an ongoing P-II/III JZP458-201 trial evaluating Rylaze in pediatric and adult patients aged ≥1mos. with ALL or LBL who are allergic […]readmore
Biosimilars
Regulatory
Innovent’s Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) Receive the NMPA’s
Shots: The approval is based on P-III ORIENT-32 study involves assessing efficacy and safety of Tyvyt + bevacizumab vs sorafenib in 571 patients in a ratio (2:1) as a 1L […]readmore
Shots: The EC approval is based on data from an ongoing P-II trial evaluating Libtayo in 119 patients with LA BCC or metastatic BCC (nodal or distant) previously treated with […]readmore
Shots: The EC approval is based on the P-III EMPOWER-Lung 1 trial evaluating Libtayo (350mg, q3w, for 108 wks.) monothx. vs platinum doublet CT as 1L treatment in 710 patients […]readmore
Shots: The opinion is based on data from the 3 P-III studies i.e Measure Up 1, Measure Up 2 & AD Up evaluating the safety & efficacy of Rinvoq (15/30 […]readmore
Shots: The approval is based on the results from two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi (dry syrup, 60mg) in infants with symptomatic Type 1 […]readmore
Shots: The approval is based on the P-III VICTORIA trial involves assessing Verquvo (2.5mg, 5mg & 10mg) in patients with CHF, published in NEJM in Mar’20. The therapy is being […]readmore
Shots: The approval is based on efficacy & safety results from the P-III ECZTRA 1, 2 & 3 trials which evaluates Adtralza (300mg, SC) as monthx vs PBO in 1900+ […]readmore
Shots: The conditional approval is based on P-II SPRINT Stratum 1 trial assessing selumetinib (PO, bid) as monothx. in pediatric patients aged >3yr. with NF1-related inoperable PNs. The trial was […]readmore