IND submission for NDI-219216 completed with plans to initiate clinical trial in 1H 2025 for treatment of MSI-H tumors January 15, 2025
Supplemental NDA for cabozantinib in pNET and epNET patients no longer the subject of discussion at an ODAC meeting January 15, 2025
Azenosertib Fast Track Designation granted for Cyclin E1 positive patients by US FDA January 15, 2025
Novel CPT1 pathway inhibitor received Orphan Drug Designation from the FDA for treating malignant gliomas January 15, 2025
ELC-100 receives Orphan Drug Designation in the U.S. for the treatment of pancreatic neuroendocrine tumors January 15, 2025
FDA Acceptance and Priority Review of NDA for Avutometinib + Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer Announced January 7, 2025
NDA submitted to US FDA for Accelerated Approval for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma January 7, 2025
US FDA Accepts for Priority Review NDA for Taletrectinib for the Treatment of Advanced ROS1+ve NSCLC December 31, 2024
Datopotamab Deruxtecan Application in the EU for Patients with Advanced non-sqNSCLC Voluntarily Withdrawn December 31, 2024
FDA issues CRL for BLA for fixed combination of amivantamab and human hyaluronidase for SC amivantamab in patients with NSCLC with EGFR mutations December 26, 2024
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for 2L Treatment of ES-SCLC December 26, 2024
Type II variation application submitted to the EMA seeking approval of IMBRUVICA in adult patients with 1L MCL eligible for auto SCT December 25, 2024
U.S. FDA Fast Track Designation for NX-5948 for the Treatment of R/R Waldenstrom’s Macroglobulinemia December 25, 2024
Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer Announced December 25, 2024
