FDA Clears IND for KTX-2001 in metastatic CRPC; Clinical Trial Collaboration with Bayer for Supply of Darolutamide announced August 11, 2025
FDA clears IND for Ph 2 trials for RC148 in multiple advanced malignant solid tumors in the US August 11, 2025
Supplemental NDA submitted to FDA for fixed-duration, all-oral combo regimen of VENCLEXTA and acalabrutinib in 1L CLL patients August 5, 2025
Positive FDA Feedback and Advances Toward IND for (Z)-Endoxifen Clinical Program in ER+/HER2- Metastatic Breast Cancer Announced August 5, 2025
Approval of the third of four stages of the Ph 1/2 study of AB8939 in R/R AML patients announced August 5, 2025
FDA Fast Track Designation for CLD-201 (SuperNova) for the Treatment of Patients with Soft Tissue Sarcoma August 5, 2025
JSKN003 Received FDA IND Approval to Initiate Ph 2 Study for Platinum-Resistant Ovarian Cancer August 5, 2025
NMPA and FDA approve initiation of Ph 2 trial (COMPASSION-36/AK104-225) of cadonilimab combo in previously treated HCC patients August 5, 2025
FDA Clears IND application for Ph 1/2 Trial of ABT-301 Triplet Therapy for Advanced CRC August 5, 2025
Imfinzi granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and GEJ cancers July 29, 2025
Positive CHMP Opinion for VORANIGO® (vorasidenib) for the Treatment of Adults and Adolescents with Grade 2 IDH-mutant Diffuse Glioma July 29, 2025
NMPA accepts NDA for sevabertinib (BAY 2927088) for previously treated NSCLC patients with HER2/ERBB2 mutations July 29, 2025
FDA Breakthrough Therapy Designation for Elironrasib for KRAS G12C-mutated locally advanced or metastatic NSCLC July 29, 2025
