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
FDA granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG) April 7, 2026
FDA granted Fast Track designation for A2B543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression April 7, 2026
