FDA clears new IND for GTB-5550 in multiple myeloma (MM) under an investigator sponsored trial (IST) protocol September 22, 2026
US FDA Breakthrough Therapy Designation for RASONQUE™ (daraxonrasib) + Chemo for 1L Metastatic Pancreatic Cancer September 22, 2026
FDA approves supplemental NDA for IBTROZI® (taletrectinib) for the treatment of locally advanced or metastatic ROS1+ NSCLC September 22, 2026
End-of-Phase 1 Meeting with FDA and Receipt of Fast Track Designation for LYT-200 in R/R High-Risk MDS Announced September 22, 2026
FDA clears IND application to initiate Ph 1 study for PRT13722 for HR+/HER2- breast cancer patients September 16, 2026
FDA “Study May Proceed” Notice and IND Clearance Received for the Evaluation of TBS-2025 in Molecularly Defined Subsets of AML and Other Blood-Related Cancers September 16, 2026
US FDA IND Clearance and Australian Regulatory Clearance granted for [²²⁵Ac]Ac-FL-261 Ph 1 Clinical Trial September 16, 2026
FDA IND clearance to initiate a first-in-human Ph 1 trial of lead peptide-drug conjugate program TS-104 September 16, 2026
FDA clears IND application for ADI-212 for the treatment of patients with metastatic CRPC September 2, 2026
DB-1317 Granted FDA Fast Track Designation for Treatment of Advanced Pancreatic Ductal Adenocarcinoma 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 clears IND application for ORM-1153 for Ph 1 study in patients with R/R AML and other hematologic malignancies August 25, 2026
FDA Fast Track Designation Granted to ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma August 25, 2026
