CHMP recommends EU approval of SC formulation of Lunsumio for people with R/R follicular lymphoma September 23, 2025
Two Positive EU CHMP Opinions for KEYTRUDA, for SC Administration and for New Indication for Earlier-Stage Head and Neck Cancer September 23, 2025
Type A meeting with FDA completed to discuss the CRL for RP1 + nivolumab BLA in melanoma September 23, 2025
Revuforj® (revumenib) Included in NCCN Guidelines for the Treatment of R/R NPM1 Mutated AML September 23, 2025
New Data Supports Initiation of Ph 3 RASolute 303 Registrational Trial of Daraxonrasib in 1L Metastatic Pancreatic Ductal Adenocarcinoma September 16, 2025
Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated with Bevacizumab September 16, 2025
NMPA accepts NDA for KN026 in patients with HER2+ve locally advanced, recurrent, or metastatic gastric or GEJ cancer September 16, 2025
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
