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

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...

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

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...

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

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

March 1st Week, 2025 Regulatory Events 🎯  Bristol Myers Squibb ’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by...

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