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
Preliminary Clinical Data for CT0596 Announced, Demonstrating Favorable Safety and Efficacy May 13, 2025
Tuspetinib-based Triplet regimen in 1L AML Patients in Ph 1/2 TUSCANY Trial Demonstrates Safety, Complete Remissions May 6, 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for 1L CLL May 6, 2025
