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
Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma April 15, 2026
