14/09/2026 US FDA reduces IMDELLTRA monitoring time to 6–8 hours, expanding Community Oncology Access BioNTech & Onco4's gotistobart doubled mOS vs docetaxel in non-pivotal part of the Ph3 PRESERVE-003 trial US FDA grants Breakthrough Therapy Designation to RASONQUE™ (daraxonrasib) + chemotherapy for first‑line metastatic pancreatic cancer In the Ph3 DESTINY-Lung04 trial, trastuzumab deruxtecan improved median PFS by 6 months vs pembro + chemo, in 1L HER2-mutant NSCLC pts Pos

08/09/2026 Imfinzi + Imdelltra demonstrated significant benefit in 1st‑line ES‑SCLC maintenance In registrational Phase 2 QUINTESSENTIAL trial, GPRC5D CAR T therapy (arlo‑cel) achieved significant ORR improvement in heavily pretreated multiple myeloma INBRX‑106 + pembrolizumab elicited strong ORR signal in Phase 2 part of Ph2/3 HexAgon-HN trial, driving expansion and FDA‑aligned path to Phase 3 confirmatory trial in HNSCC Imfinzi + Imdelltra demonstrated significant benefit i