ImmunityBio resubmits FDA application for ANKTIVA in bladder cancer after agency requests updated efficacy data

By on    Pharma & Biotech  

ImmunityBio resubmits FDA application for ANKTIVA in bladder cancer after agency requests updated efficacy data

ImmunityBio has resubmitted its supplemental biologics license application to the U.S. Food and Drug Administration for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guerin for BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors, after the agency requested updated long-term efficacy data in March 2026. The resubmission follows a regulatory exchange that began in January […]

Co-Diagnostics secures Australian patent for Co-Dx PCR platform, marking global IP expansion milestone

By on    Medical Devices & Diagnostics  

Co-Diagnostics secures Australian patent for Co-Dx PCR platform, marking global IP expansion milestone

Co-Diagnostics, Inc. has received its first international patent for its Co-Dx PCR platform, with the Australian Patent Office granting coverage for the point-of-care molecular diagnostics system, including its PCR Pro instrument and disposable test cups. This development marks a critical step in the U.S.-based company’s international intellectual property strategy as it advances toward global commercialization […]