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
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma November 15, 2024
FDA gives clearance to commence Ph 2 trial of leronlimab in patients with R/R MSS CRC November 13, 2024
Type C Meeting granted with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed GBM November 13, 2024
Applications submitted in the U.S. and EU seeking approval of DARZALEX FASPRO / DARZALEX as SC monotherapy for high-risk smoldering multiple myeloma November 12, 2024
Orphan Drug Designation from the US FDA for LBL-034 for the Treatment of Multiple Myeloma November 12, 2024
Orphan Drug Designation by US FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma November 12, 2024
NDA Submitted to the U.S. FDA for Sunvozertinib in Treating R/R NSCLC with EGFR Exon 20 Insertion Mutations November 12, 2024
FDA Regenerative Medicine Advanced Therapy (RMAT) Designation granted to ALLO-316 for Adult Patients with Advanced or Metastatic RCC November 5, 2024
Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer Completed November 5, 2024
FDA clearance to commence Ph 2 trial of leronlimab in patients with R/R microsatellite stable CRC November 5, 2024
