German federal authority approves CTA to initiate Ph 1/2a trial of CC-38 in patients with metastatic CRC and metastatic prostate cancer August 19, 2025
FDA IND application for ST-01156 Ph 1 trial in patients with advanced solid tumor and heme malignances August 19, 2025
FDA Accepts NDA for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer August 12, 2025
NMPA accepts supplementary NDA for Toripalimab in 1L HER2-expressing Urothelial Carcinoma August 11, 2025
FDA & NMPA’s approval to initiate Ph 2 COMPASSION-36/AK104-225 registrational trial of cadonilimab + lenvatinib combo in IO-refractory HCC announced August 11, 2025
FDA Grants Priority Review to Breyanzi (lisocabtagene maraleucel) for R/R Marginal Zone Lymphoma August 11, 2025
Positive Feedback Received from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer with CPS <1 August 11, 2025
Regulatory Clearance obtained to Initiate Ph 1 Trial for PQ203 in the U.S. and Canada; FDA Fast Track Designation Granted August 11, 2025
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
