Successful pre-BLA meeting with the US FDA to support BLA for RP1 (vusolimogene oderparepvec) in anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024 announced September 17, 2024
FDA Clears IND Application for Ph 1/2 Clinical Trial of an AAV-delivered Cancer Immunotherapy, VNX-101 September 17, 2024
Fast Track Designation Granted for VMT01 for the Diagnosis & Treatment of MC1R-Positive Melanoma September 10, 2024
FDA Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in R/R AML September 10, 2024
FDA Orphan Drug Designation for ABD-147 for the Treatment of Neuroendocrine Carcinoma September 10, 2024
Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma September 10, 2024
Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers September 3, 2024
Supplemental NDA for fruquintinib + paclitaxel for treatment of 2L advanced gastric or GEJ adenocarcinoma voluntarily withdrawn in China September 3, 2024
CDE of NMPA Approves to Initiate Ph 3 Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor September 3, 2024
NMPA approves Supplemental BLA for Carteyva® in Adult Patients with R/R Mantle Cell Lymphoma September 3, 2024
FDA accepts Supplemental BLA for 1L HCC based on Ph 3 CheckMate -9DW trial demonstrating improved survival with Opdivo + Yervoy vs SoC; PDUFA: Apr 2025 August 27, 2024
FDA issues a CRL for linvoseltamab’s BLA in R/R multiple myeloma that has progressed after at least three prior therapies August 27, 2024
FDA grants Breakthrough Therapy Designation to GSK5764227 for R/R extensive-stage SCLC August 27, 2024
TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA for locally advanced or metastatic EGFR-mutant NSCLC August 27, 2024
Human Research Ethics Committee (HREC) in Australia clears initiation of Ph 1 trial of MNPR-101-Lu August 27, 2024
