FDA provides Feedback in Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors October 28, 2026
CHMP recommends approval of TALVEY® (talquetamab) plus daratumumab in earlier line treatment of relapsed/refractory multiple myeloma October 27, 2026
New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) accepted for review by the China NMPA October 27, 2026
FDA granted Fast Track designation to QTX3034 + cetuximab for KRASG12D-mutant CRC, with or without FOLFOX chemotherapy October 20, 2026
RASONQUE™ (daraxonrasib) Receives Positive CHMP Opinion Recommending Marketing Authorization in European Union for Metastatic Pancreatic Cancer October 20, 2026
FDA cleared IND application for LB2501 for R/R B-cell malignancies, including B-cell NHL October 20, 2026
FDA grants Fast-Tracks designation to Invikafusp Alfa for Previously Treated TMB-High Solid Tumors October 20, 2026
NDA resubmitted to FDA for Camrelizumab + Rivoceranib in 1L Unresectable or Metastatic HCC October 20, 2026
Opamtistomig Granted FDA Fast Track Designation for 1L Advanced or Metastatic Biliary Tract Cancer October 14, 2026
EMA validates the MAA for Wevdury® (fuzuloparib) in combination with abiraterone acetate and prednisone/prednisolone for metastatic CRPC patients October 14, 2026
Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the US FDA for CRC and NSCLC October 14, 2026
FDA Alignment obtained on ENABLE-2 Ph 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated CLL October 14, 2026
Type B meeting provided clear guidance for next steps to prepare IND application for HCW11-018b in solid tumors October 14, 2026
FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of NSCLC October 6, 2026
NDA Submission Initiated for Zipalertinib + Chemo in 1L EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program October 6, 2026
