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

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma ( Ref )...

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

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC ( Ref ) The US FDA approved...

22/06/2025 The Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab achieved significant OS benefit in metastatic colorectal cancer...

19/06/2025 Initial patient screening completed in Transgene's Phase 2 trial of TG4050 vaccine in resectable SCCHN ( Ref ) Transgene...

18/06/2025 The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients ( Ref...

3rd June, 2025 Regulatory Events   🎯 The US FDA approved the updated labelling of  Pfizer ’s talazoparib (PARP inhibitor) + enzalutamide...

June 2nd Week, 2025 Regulatory Events   🎯 The US FDA approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a...

May 5th Week, 2025 Regulatory Events 🎯 The EC approved  Bristol Myers Squibb ’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1)...

May 1st Week, 2025 Regulatory Events   🎯  Summit Therapeutics, Inc.  and  Akeso Biopharma ’s ivonescimab (PD-1 x VEGF BsAb) mono has...

April 3rd Week, 2025 Regulatory Events   🎯  Bristol Myers Squibb ’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved...

April 1st Week, 2025 Regulatory Events 🎯  AstraZeneca 's neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab...

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...

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...

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive...