FDA Clears IND Application for Ph 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic CRC December 4, 2024
Results from End-of-Phase 2 Meeting with FDA for IMNN-001 Program in Advanced Ovarian Cancer Announced November 26, 2024
FDA Accepts Supplemental NDA for NUBEQA® (darolutamide) for the Treatment of Patients with Metastatic HSPC November 26, 2024
Breakthrough Therapy Designation for RP1 and RP1 BLA submitted to the FDA under the Accelerated Approval Pathway November 26, 2024
FDA Granted Orphan Drug Designation of LBL-024 for Treatment of Neuroendocrine Cancer November 26, 2024
NDA for Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA November 26, 2024
Blenrep combinations accepted for review by the FDA for the treatment of R/R multiple myeloma November 26, 2024
Positive CHMP Opinion for Repotrectinib for the Treatment of Advanced ROS1-Positive NSCLC and Advanced NTRK-Positive Solid Tumors November 19, 2024
FDA Fast Track Designation for ALE.P02 for the Treatment of CLDN1+ Squamous Solid Tumors November 19, 2024
NDA for Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA November 19, 2024
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated NSCLC November 19, 2024
FDA Rare Pediatric Disease Designation Granted to Elraglusib for Treatment of Ewing Sarcoma November 19, 2024
FDA Study May Proceed Letter received for Pivotal Ph 3 Trial of Amezalpat Combination Therapy for the Treatment of 1L HCC November 19, 2024
Institutional Review Board Approves MIRACLE Ph 3 Pivotal Trial of Annamycin in Combination with Cytarabine for the Treatment of R/R AML November 19, 2024
Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) + Chemo as 1L Treatment for Adult Patients With Unresectable Non-Epithelioid MPM November 19, 2024
CHMP recommends RYBREVANT® (amivantamab) + LAZCLUZE® (lazertinib) for 1L treatment of patients with EGFR-mutated advanced NSCLC November 19, 2024
Positive CHMP Opinion for Opdivo® (nivolumab) + Yervoy® (ipilimumab) for the First-Line Treatment of Adult Patients with MSI-H or MRD Metastatic CRC November 19, 2024
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer based on Ph 3 LAURA trial results November 19, 2024
