FDA accepted relacorilant NDA for patients with platinum-resistant ovarian cancer; PDUFA date: Jul 11, 2026 September 16, 2025
FDA grants HERNEXEOS® Breakthrough Therapy Designation in HER2 (ERBB2)m advanced 1L NSCLC September 10, 2025
Olomorasib receives U.S. FDA’s Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers September 9, 2025
Regulatory Update on Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA Announced September 9, 2025
FDA granted Breakthrough Therapy Designation and Orphan Drug Designation for D3S-001 for Patients with KRAS G12C-Mutated Cancers September 3, 2025
FDA INTERACT meeting completed in preparation to advance TBC-1 toward IND-enabling studies September 3, 2025
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
