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
CTIM-76 Receives FDA Fast Track Designation for the Treatment of Platinum-Resistant Ovarian Cancer April 7, 2026
Type C FDA Meeting Announced to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer April 7, 2026
FDA Accepts Priority Review of NDA for Lirafugratinib as 2L Cholangiocarcinoma Treatment April 7, 2026
