Fast Track Designation for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma May 12, 2026
US FDA Fast Track Designation for Zocilurtatug Pelitecan (Zoci) for Treatment of Extrapulmonary Neuroendocrine Carcinomas (epNECs) May 12, 2026
FDA Expanded Access Authorization for Daraxonrasib in Patients with Previously Treated Metastatic Pancreatic Cancer May 6, 2026
Ph 2/3 Clinical Trial Application submitted to Germany’s BfArM for SIL204 in KRAS-Driven Locally Advanced Pancreatic Cancer May 6, 2026
US FDA Accepts NDA for Zipalertinib for the Treatment of Locally Advanced or Metastatic NSCLC with EGFR Exon 20 Insertion Mutations May 6, 2026
US FDA RMAT Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies May 6, 2026
FDA ODAC didn’t reach a majority vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR+ve HER2neg breast cancer May 6, 2026
NDA Submission initiated from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence RTOR Program May 6, 2026
Taletrectinib (IBTROZI®) Added as Recommended Option to NCCN Guidelines for CNS Cancers April 28, 2026
FDA Accepts for Priority Review Supplemental BLA for Ziihera® (zanidatamab-hrii) Combo in 1L HER2+ Locally Advanced or Metastatic GEA April 28, 2026
Type C meeting with FDA provides alignment on design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic SCAC April 28, 2026
FDA Fast Track Designation for BBO-11818 for Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma April 28, 2026
FDA extends review period for Sarclisa (isatuximab-irfc) SC BLA by up to 3 months; new target action date July 23, 2026 April 28, 2026
Clinical Trial Application approved for CryptiVax-1001 OVACT trial in Advanced High-Grade Serous Ovarian Cancer April 28, 2026
