FDA Approves Revuforj® (revumenib) for Adult and Pediatric Patients with R/R Acute Leukemia with a KMT2A Translocation November 19, 2024
FDA approved Danziten™ (nilotinib with no mealtime restrictions) in 1L Ph+ CP CML and imatinib-treated AP Ph+ CML November 16, 2024
FDA approved obecabtagene autoleucel (Aucatzyl) for adults with R/R B-cell precursor acute lymphoblastic leukemia (ALL) November 12, 2024
FAILED TRIAL: Ph 2/3 Study of Uproleselan Did Not Meet Primary Endpoint of EFS improvement in elderly 1L AML patients November 5, 2024
FDA approved Scemblix in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile November 5, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric AML October 22, 2024
Galecto Completes Strategic Review to Focus on Oncology and Liver Disease and Acquires AML Preclinical Asset from Bridge Medicines October 8, 2024
FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in 1L AML for Patients Unfit for Induction Chemotherapy Treatment September 24, 2024
First patient dosed in Investigator-initiated Ph Ib study of iadademstat in 1L AML September 18, 2024
GBM program of INB-200 and INB-400 to be suspended; AML program of INB-100 to be prioritized September 10, 2024
New clinical data from ongoing Ph 1/2 VBP101 study of patients with R/R AML receiving trem-cel followed by Mylotarg announced September 10, 2024
FDA Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in R/R AML September 10, 2024
Positive Results Announced From Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ ALL September 3, 2024
Nadunolimab clinical trials in AML/MDA and TNBC to be initiated in Q4 2024 and H2 2025, respectively September 3, 2024
Enrollment discontinued in SELECT-AML-1 Ph 2 trial of tamibarotene + venetoclax & azacitidine in newly diagnosed, unfit AML patients with RARA gene overexpression August 22, 2024
Ph 3 SIERRA trial deemed inadequate to support BLA filing for Iomab-B; additional head-to-head RCT demonstrating OS benefit required August 22, 2024
FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia August 13, 2024
