Type A meeting scheduled with FDA scheduled to discuss CRL for BLA for RP1 + nivolumab combo in advanced melanoma September 3, 2025
TT125-802 received two Fast Track designations in patients with NSCLC with either EGFR Ex19del or Ex21 L858R substitution mutation or KRAS-G12C mutation September 3, 2025
NDA Submission of Gedatolisib in PIK3CA WT Cohort in HR+/HER2- Advanced Breast Cancer to be Initiated Under FDA’s RTOR Program September 3, 2025
FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S®) in Advanced Endometrial Cancer September 3, 2025
ATG-022 Granted Breakthrough Therapy Designation for the Treatment of Gastric/GEJ Adenocarcinoma August 26, 2025
FDA accepted Type C meeting request for Doxorubicin Containing Novel Microneedle Array (D-MNA); SKNJCT-003 Ph 2 study randomize more than 75% of patients August 26, 2025
Premarket approval (PMA) application submitted to FDA for Tumor Treating Fields (TTFields) therapy for the treatment of locally advanced pancreatic cancer August 26, 2025
FDA clears IND application of 7MW4911 to initiate Ph 1/2 trial in patients with advanced CRC and other advanced gastrointestinal tumors August 26, 2025
Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage SCLC August 19, 2025
Bexmarilimab to advance into registrational Ph 2/3 study in 1L HR-MDS after positive meeting with the FDA August 19, 2025
Izalontamab Brengitecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated NSCLC August 19, 2025
Global Registrational Ph 3 Study of Lisaftoclax for 1L Higher-Risk MDS Cleared by US FDA and EMA August 19, 2025
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
