FDA Granted Orphan Drug Designation to Utidelone for the Treatment of Pancreatic Cancer September 30, 2025
FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib) September 30, 2025
IND application amended with updated OS data from Ph 2 Actuate-1801 Part 3B trial of elraglusib + GnP versus GnP alone in 1L metastatic pancreatic cancer September 23, 2025
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
