14/10/2026 ImmunityBio secures US FDA expansion for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer Tab-cel BLA resubmission accepted by US FDA for EBV+ PTLD; PDUFA date set for March 2027 ImmunityBio secures US FDA expansion for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer (Ref) The US FDA expanded the approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln; IL-15 receptor agonist) in combination with BCG to include patients with BCG-unresponsive non-muscle-inva

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