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
IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Ph 1 Study in MSI-High Solid Tumors Announced November 5, 2024
FDA Clears IND Application for ATX-559 Ph 1 study in solid tumor patients with a focus on BRCA1/2-deficient breast cancer and MSI-H and dMMR solid tumors October 29, 2024
FDA’s Oncologic Drugs Advisory Committee Decision on use of Multikine® in PD-L1 Negative Cancer Patients announced October 29, 2024
FDA accepts NDA for UGN-102 (mitomycin) for intravesical solution for the treatment of LG-IR-NMIBC; PDUFA goal date: Jun 2025 October 22, 2024
Positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer October 22, 2024
Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Ph 3 trial in patients with recurrence of prostate cancer October 22, 2024
US FDA issues Study May Proceed letter for the Pilot Study of Pidnarulex PD in Patients with Advanced Solid Tumors October 22, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric AML October 22, 2024
IND Application for Ph 3 Study of Neoadjuvant KN026 +Albumin-bound Docetaxel in Breast Cancer Approved October 22, 2024
