28/04/2026 FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027 FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint FDA accepts NDA for zipalertinib in EGFR exon 20–

31/03/2026 Caribou Biosciences' CB-011 received the FDA RMAT designation for multiple myeloma Caribou Biosciences' CB-011 received the FDA RMAT designation for multiple myeloma ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Caribou Biosciences' CB-011 (allogeneic anti-BCMA CAR-T) for relapsed or refractory multiple myeloma (r/r MM). The cell therapy is b eing evaluated in the open-label, multicenter Phase 1 CaMMouflage clinical tri

09/02/2026 Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA ( Ref ) CARsgen Therapeutics submitted the New Drug...

May 5th & June 1st Week ⭐ Regulatory Updates 🎯 China’s NMPA granted Priority Review to CARsgen Therapeutics ’ satri-cel (CT041; an...

May 3rd Week, 2025 ⭐ Regulatory Update 🎯 The US FDA granted the RMAT designation to BrainChild Bio ’s BCB-276 (an autologous, B7-H3...

April 3rd & 4th, 2025 Regulatory Updates 🎯 The UK MHRA granted conditional marketing authorization for Autolus Therapeutics ’...

February 4th Week, 2025 📝 The US FDA granted RMAT designation for ImmunityBio ’s Anktiva (n ogapendekin alfa inbakicept; IL-15...