01/10/2026 Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC Trethera receives FDA Fast Track Designation for TRE-515 combination strategy in KRAS G12C-Mutant NSCLC Replimune announces US launch of TUDRIQEV™ for advanced Melanoma Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC (Ref) Cullinan Therapeutics announced the initiation of a US FDA New Drug Application (NDA) submission under the

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA (Ref) The US FDA granted the Breakthrough Device designation to Artera's ArteraAI Prostate (an AI precision medicine tool) intended to assist clinicians with risk-based decisions for patients with localized prostate cancer ArteraAI Prostate analyzes digital pathology images of the prostate cancer biopsy slide to prognosticate long-term outcomes, such as 10-yr risk of distant met