IND Submission to US FDA for Ph 1/2 study of Silmitasertib (CX-4945) in children and young adults with R/R solid tumors July 17, 2024
505(b)(2) NDA for Lutetium Lu 177 Dotatate Injection submitted to the FDA for the treatment of somatostatin receptor-positive GEP-NETS July 17, 2024
US FDA grants IND Clearance to Conduct Ph 1/2 Study of JCXH-211 IV as Monotherapy and with Checkpoint Inhibitor in Patients with Advanced Solid Tumors July 17, 2024
HREC Approval and CTN Clearance granted from the TGA to Commence a Ph 1 Clinical Trial for INT2104 for B Cell Malignancies July 17, 2024
Plans for Near-Term Resubmission of NDA for 1L Treatment Option for Unresectable HCC Following Type A FDA Meeting Reported July 17, 2024
Application filed for for FDA Orphan Drug Designation for Namodenoson in the Treatment of Pancreatic Cancer July 17, 2024
BLA resubmitted to the FDA for cosibelimab for patients with metastatic or locally advanced cSCC not candidates for curative surgery or curative radiation July 9, 2024
CHMP adopts positive opinion for BALVERSA (erdafitinib) in unresectable/metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations July 9, 2024
NMPA accepts NDA for Tazemetostat for the Treatment of R/R Follicular Lymphoma with Priority Review Status July 9, 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with MMR-proficient advanced or recurrent endometrial cancer July 9, 2024
FDA Granted Fast Track Designation for 225Ac-FL-020 for the Treatment of Metastatic CRPC July 9, 2024
Patritumab Deruxtecan BLA Submission Receives CRL from FDA Due to Inspection Findings at Third-Party Manufacturer July 1, 2024
FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric ALL July 1, 2024
