SANOVO Trial Demonstrated Significant PFS Benefit of ORPATHYS + TAGRISSO in 1L Patients with MET-Overexpressing EGFR-mutated Lung Cancer in China September 2, 2026
FDA clears IND application for ADI-212 for the treatment of patients with metastatic CRPC September 2, 2026
DSMB recommends termination of Ph 2 trial of adjuvant BNT122-01 in patients with circulating tumor DNA-positive, surgically resected Stage II/III CRC September 2, 2026
Ziihera® (zanidatamab-hrii) + Chemo Demonstrates Statistically Significant OS Benefit vs Trastuzumab + Chemo in 1L HER2+ Advanced GEA September 2, 2026
DB-1317 Granted FDA Fast Track Designation for Treatment of Advanced Pancreatic Ductal Adenocarcinoma September 2, 2026
DualityBio Enters a Global Collaboration and License Agreement with Genentech to Develop Next-Gen ADCs Built on DualityBio’s DUPAC Novel-Payload Platform September 2, 2026
Emmaus Life Sciences Announces Agreement for Evaluation of L-glutamine for Pancreatic Cancer September 2, 2026
First Patient Dosed in Ph 3 Study of ASP2138 in CLDN18.2+ve and HER2-neg locally advanced unresectable or metastatic GEJ adenocarcinoma September 2, 2026
First patient dosed in Ph 1 KOALA trial of KMCAR™ T-cell therapy in patients with R/R kappa-restricted multiple myeloma September 2, 2026
First patient dosed in Ph 1 trial of ABSK211 for advanced solid tumors with KRAS alterations September 2, 2026
Confirmed Durable Partial Response Achieved in Ph 1 Trial of RAD204 in Patients with Advanced Solid Tumors Post-Immunotherapy September 2, 2026
Ivonescimab + Chemo Global Ph 3 HARMONi Primary Analysis Results Published in The Lancet Oncology September 2, 2026
Updated NEST Ph 2 Publication Reporting Deep Pathologic Responses and No Observed Recurrences with Neoadjuvant BOT+BAL in Resectable Colon Cancer September 2, 2026
Ivonescimab + Chemo Demonstrates Statistically Significant OS Benefit vs Durvalumab + Chemo in 1L Advanced BTC in China September 2, 2026
NMPA Approves ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma September 2, 2026
SYS6090 (JMT108) Granted Fast Track Designation by FDA for Treatment of Patients with MSS/pMMR mCRC September 2, 2026
Successful FDA Type C Meeting conducted for IDE849 on Ph 3 Registrational Trial Design for Potential Accelerated and Full Approval in ES-SCLC September 2, 2026
Supplemental NDA submitted to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer September 2, 2026
Supplemental NDA to FDA submitted for Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis September 2, 2026
MT027 Receives FDA IND Clearance to Proceed to Ph 2 clinical Trial for Recurrent GBM September 2, 2026
FDA Fast Track Designation for Varsetatug masetecan (Varseta-M) for R/R Metastatic CRC September 2, 2026
FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab + Chemo in 1L HER2+ Advanced Gastroesophageal Adenocarcinoma September 2, 2026