16/06/2026 US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer (Ref) ABL Bio & NovaBridge's givastomig, a CLDN18.2 x 4-1BB bispecific antibody, received Fast Track status in combination with nivolumab and chemotherapy for first-line HER2-negative advanced/metastatic gastroesophageal adenocarcinomas that are CLDN18.2 and PD-L1 positive Clinica

08/04/2026 FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas FDA Grants Orphan Drug Designation to Compass Therapeutic’s Tovecimig for Biliary Tract Cancer FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas (Ref) Plus Therapeutics’ REYOBIQ™ (rhenium Re186 obisbemeda) has been granted orphan drug status for pediatric malignant gliomas, with scope expanded to include pediatric ependymoma Regula