FDA Approves Larger Vial Size for Nelarabine IV Administration for the Treatment of T-ALL and T-LBL February 1, 2026
FDA Grants Breakthrough Therapy Designation to WU-CART-007 for Treatment of R/R T-ALL/LBL January 25, 2026
Global Registrational Ph 3 Study of Olverembatinib in 1L Ph+ ALL Cleared by FDA and EMA December 9, 2025
NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Option for Adult Patients with R/R B-ALL December 2, 2025
Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with R/R B-ALL May 27, 2025
MHRA grants conditional marketing authorisation for AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with R/R B-ALL April 30, 2025
Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) ALL March 11, 2025
FDA approved obecabtagene autoleucel (Aucatzyl) for adults with R/R B-cell precursor acute lymphoblastic leukemia (ALL) November 12, 2024
Positive Results Announced From Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ ALL September 3, 2024
FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to UCART22 product candidate for ALL Treatment July 30, 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
FDA clears IND for Ph 1/2a trial (TCX-101) of BSB-1001 for patients with R/R AML, ALL and MDS, in conjunction with alloHSCT June 11, 2024
FDA grants RMAT designation to TSC-100 & TSC-101 for the treatment of patients with AML, ALL, and MDS undergoing allogeneic HCT with reduced intensity conditioning June 4, 2024
FDA grants accelerated approval to ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL March 26, 2024
