August 1st Week, 2025 Regulatory Events   🎯  AbbVie  submitted a sNDA to the US FDA for AbbVie and  Roche ’s venetoclax (BCL-2...

July 4th Week, 2025 Regulatory Events   🎯 The EC approved  Bayer  and  Orion Pharma ’s darolutamide (androgen receptor inhibitor) +...

July 3rd Week, 2025 Regulatory Updates   🎯  Corcept Therapeutics  submitted an NDA to the US FDA for relacorilant (selective cortisol...

July 2nd Week, 2025 Regulatory Updates   🎯 The EC approved  BeOne Medicines ' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the...

July 1st Week, 2025 Regulatory Updates 🎯 The US FDA granted accelerated approved for  Dizal Pharmaceutical ’s sunvozertinib (EGFR TKI)...

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

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

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

June 1st Week, 2025 Regulatory Events 🎯  Takeda  and  Pfizer ’s brentuximab vedotin (Adcetris; CD30 ADC) + ECADD chemo regimen has been...

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

May 4th Week, 2025 Regulatory Events   🎯 The US FDA granted a Fast Track designation to  CSPC Pharmaceutical Group  ’s CPO301 (SYS6010;...

May 3rd Week, 2025 Regulatory Events   🎯  Incyte  and  MacroGenics, Inc. ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been...

May 2nd Week, 2025 Special Designations ⭐ The US FDA granted the Fast Track designation to  Adcentrx Therapeutics ’ ADRX-0706 (Nectin-4...

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

April 4th Week, 2025 Regulatory & Market News 🎯  Akeso Biopharma ’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for...

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

April 2nd Week, 2025 Regulatory Events   🎯 AstraZeneca  and  Daiichi Sankyo ’s trastuzumab deruxtecan (HER2 ADC) mono has been approved...

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

March 4th Week, 2025 Regulatory Events 🎯  CStone Pharmaceuticals  submitted a Type II variation application to the EMA for sugemalimab...

March 3rd Week, 2025 Regulatory Events   🎯 The US FDA granted traditional approval to Merck & Co./ MSD ’s pembrolizumab (anti-PD-1) +...