Positive Data from Long-Term Follow-Up Analysis of the Ph 3 AGILE Trial of TIBSOVO® (ivosidenib) in IDH1-mutated AML Announced July 29, 2025
Aptose and Hanmi Enter New Loan Agreement to Advance Development of Tuspetinib in Triplet Therapy for AML July 23, 2025
All Primary Endpoints Met in Ph 2 Trial of SLS009 in R/R AML; FDA Guidance Received to Advance into 1L Therapy Study July 23, 2025
Supplemental NDA for INQOVI (decitabine & cedazuridine) + venetoclax for 1L AML adults ineligible for intensive induction chemo accepted by FDA July 15, 2025
Lisaftoclax (APG-2575) approved by China’s NMPA for the treatment of adult 2L+ CLL/SLL patients July 15, 2025
FDA grants Priority Review to Supplemental NDA for Revuforj® (revumenib) in R/R mNPM1 AML; PDUFA action date Oct 2025 July 1, 2025
First Patient Completes DLT Observation Period with No Reported DLTs in Ph 1 Trial of CER-1236 June 24, 2025
Fixed-duration Calquence-based regimens approved in EU for 1L CLL patients based on AMPLIFY Ph 3 trial results June 11, 2025
FDA Accepts and grants Priority Review of NDA for Ziftomenib in Adults with R/R NPM1-Mutant AML June 3, 2025
Helix BioPharma Secures Pre-IND Candidates LEUMUNA™ and GEMCEDA™ in Strategic Acquisition from the Laevoroc Group May 27, 2025
Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with R/R B-ALL May 27, 2025
EMA approves CTA to conduct pivotal Ph 2B/3 trial of Annamycin + cytarabine in R/R AML patients May 21, 2025
