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...