18/02/2026 ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS (Ref) The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept) +

07/07/2025 SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC (Ref) The US FDA approved Sirtex Medical's SIR-Spheres Y-90 resin microspheres for the Tx of unresectable HCC The approval is based on the results from the prospective, multi-center, open-label DOORwaY90 trial DOORwaY90 met its prespecified primary endpoints with a ORR of 98.5%; the median DoR exceeded 300 days Matt Schmidt, CEO, Sirtex: "The expanded indication makes SIR-Spheres® the only Y-90 tr

February 4th Week, 2025 📝 The US FDA granted RMAT designation for ImmunityBio’s Anktiva (n ogapendekin alfa inbakicept; IL-15 superagonist) and its PD-L1 t-haNK (an allogeneic, a-PD-L1 CAR-NK) for the reversal of lymphopenia in patients receiving SOC chemo/radiotherapy and in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer (Ref 1) ❓ What are the next steps in the development process for Anktiva and PD-L1 t-haNK following the RMAT designation? 📝 UCARsgen

Bladder cancer is the most common malignancy of the urinary tract. As of 2022, Bladder Cancer had an incidence of 614,298 patients worldwide, and 220,596 patients succumbed to the disease. While the therapeutic approach to it remained largely unchanged for many years, recent clinical progress has paved the way towards a novel era of diagnosis and management of the disease, with several special designations and two very recent approvals by the US FDA. In December 2023, the FD