06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies ( Ref ) The US FDA accepted Orca...

September 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD ’s Keytruda Qlex (subcutaneous injection of...

September 1st Week, 2025 Regulatory Events 🎯 China’s NMPA approved  Boehringer Ingelheim ’s zongertinib (HER2-selective tyrosine kinase...

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML ( Ref ) The US FDA granted the Fast Track...

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia ( Ref ) The US FDA granted the Orphan Drug...

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

May 1st & 2nd Week, 2025 ⭐ Deals & Collaborations 🤝  NKure Therapeutics  and  CRISPR Therapeutics  partnered to co-develop CRISPR’s...

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

April 2nd April, 2025 ⭐ Regulatory Events 🎯 The US FDA cleared an IND application of  CERo Therapeutics, Inc. ’s CER-1236 (anti-Tim-4L...

Welcome to the May edition of our CGT Watch newsletter!   CARsgen’s satri-cel priority review & Ph2 results; Autolus’ obe-cel positive...

Welcome to the April edition of our CGT Watch newsletter!   Autolus’ Aucatzyl’s UK approval; BrainChild Bio’s BCB-276 BTD; Lyell’s LYL314...