15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

14/04/2026 FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma FDA sBLA Submission & NCCN Guideline Inclusion for BIZENGRI in NRG1 Fusion–Positive Cholangiocarcinoma Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement to advance OBX-115 TIL Therapy FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma ( Ref ) Renaissance Pharma's Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody, has received Fast Track status from the U.