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
Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer August 25, 2026
FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study August 25, 2026
FDA Fast Track Designation for BH-30643 for the Treatment of Advanced EGFR C797S-positive NSCLC August 25, 2026
FDA Fast Track Designation for ETX-19477 for the Treatment of Patients with BRCA-Mutated, HR+/HER2- Unresectable or Metastatic Breast Cancer August 25, 2026
