Positive feedback received from FDA on the planned TACTI-004 Ph 3 trial of eftilagimod alfa + KEYTRUDA + chemo for the treatment of 1L NSCLC July 30, 2024
Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA July 30, 2024
Ph 2 volasertib program receives “Clearance to Proceed” from the FDA and agreement on the dosing plan for Ph 2 clinical trial July 30, 2024
Positive EU CHMP Opinion for KEYTRUDA + Padcev as 1L Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma July 30, 2024
Update Provided from iSCIB1+ Clinical Advisory Meeting to Strengthen Plans for Ph 2/3 Registration Clinical Trial July 27, 2024
EMA validated Type II Application for Opdivo plus Yervoy for 1L Treatment of Unresectable or Advanced HCC July 23, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric AML July 23, 2024
End-of-Phase-2 Meeting Outcomes and Topline Interim Ph 2 Data for BOT/BAL in MSS Colorectal Cancer announced July 23, 2024
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
