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
FDA Fast Track Designation for Lunresertib in Combination with Zedoresertib for Genomic-Defined Platinum-Resistant Ovarian Cancer April 21, 2026
Supplemental BLA submitted to FDA for BIZENGRI® (zenocutuzumab-zbco) in NRG1 Fusion Positive Cholangiocarcinoma; Included in updated NCCN Guidelines April 21, 2026
Ifinatamab Deruxtecan Granted Priority Review in the US for Adult Patients with Previously Treated ES-SCLC who Experienced Disease Progression on or After Platinum-Based Chemotherapy April 21, 2026
Orphan Drug Designation Application Submitted to US FDA for SkinJect® for treating basal cell carcinoma (BCC) in patients with Gorlin Syndrome April 21, 2026
US FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for MIBC Regardless of Cisplatin Eligibility April 21, 2026
Ifinatamab Deruxtecan Granted Priority Review in the US for Adult Patients with Previously Treated ES-SCLC April 15, 2026
Alignment with FDA on Registration Path for CRB-701 in 2L HNSCC and Cervical Cancer Announced April 15, 2026
CT-P71 received Fast Track Designation from US FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma April 15, 2026
