21/01/2026 BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 ( Ref ) The US FDA granted the fast track designation to BioNTech's BNT

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA ( Ref ) The US FDA granted the...

June 4th Week,2025 Regulatory Events   🎯  Daiichi Sankyo  and  AstraZeneca 's Dato-DXd (Datroway; TROP2 ADC) has been granted an...

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

June 3rd week, 2025 Regulatory Updates    🎯  Senti Biosciences  received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or...

June 2nd week, 2025 ⭐ Deals & Collaborations   🤝Neowise Biotechnology granted  BeOne Medicines  rights to one of its proprietary...

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 ’...

March 3rd Week, 2025 Regulatory Events 🎯 The European commission granted approval to  Bristol Myers Squibb ’ Breyanzi (lisocabtagene...

March 1st Week, 2025 ⭐ Regulatory Events 🎯 China’s NMPA granted Breakthrough Therapy Designation (BTD) to  CARsgen Therapeutics ’...

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