PDUFA Action Date Extension Announced for Revumenib NDA for R/R KMT2Ar Acute Leukemia; new PDUFA action date: Dec 26, 2024 August 7, 2024
Pivotal, adaptive MIRACLE Ph 3 trial designed for possible accelerated approval of Annamycin + cytarabine for the treatment of R/R AML August 7, 2024
Scemblix® Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML based on ASC4FIRST Ph 3 study data August 6, 2024
Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved PFS in 1L CLL in AMPLIFY Ph 3 trial July 30, 2024
FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to UCART22 product candidate for ALL Treatment July 30, 2024
Regulatory path forward for uproleselan in R/R AML would require an additional clinical trial July 30, 2024
Ph 2 volasertib program receives “Clearance to Proceed” from the FDA and agreement on the dosing plan for Ph 2 clinical trial July 30, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric AML July 23, 2024
Ph 1/2 dose-escalation study of SP-2577 in combination with azacitidine in adults with MDS and CMML Placed on Partial Hold July 17, 2024
HREC Approval and CTN Clearance granted from the TGA to Commence a Ph 1 Clinical Trial for INT2104 for B Cell Malignancies July 17, 2024
FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric ALL July 1, 2024
FDA approved blinatumomab in the consolidation phase of multiphase chemo for adult & pediatric patients with CD19+ve Ph–neg B-cell precursor ALL June 18, 2024
European Commission granted Orphan Drug Designation to UCART22 for the treatment of ALL June 11, 2024
FAILED TRIAL: Uproleselan failed to demonstrate significant OS improvement for patients with primary refractory AML in pivotal Ph 3 trial June 11, 2024
