14/10/2025 Pfizer's tucatinib combination regimen significantly improved PFS as a 1L maintenance therapy in HER2+ve metastatic Breast Cancer ( Ref ) Per topline results from the Phase 3 HER2CLIMB-05 trial, Pfizer's tucatinib (tyrosine kinase inhibitor) in combination with first-line standard-of-care maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction met its primary endpoint of PFS in HER2+ metastatic breast cancer. A statistically signifi

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved  Eli Lilly and Company 's imlunestrant (oral estrogen receptor...

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast...

28/08/2025 TOLREMO Therapeutics' TT125-802 received two fast track designations from the US FDA for NSCLC ( Ref ) The US FDA granted two...

August 4th Week, 2025 Regulatory Events   🎯 Health Canada issued a NOC/c for  Iovance Biotherapeutics, Inc. 's lifileucel (autologous...

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer ( Ref )...

Health Canada approved Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) + ipilimumab (Yervoy; anti-CTLA-4) for the first-line treatment of adult patients with: Unresectable or metastatic MSI-H/dMMR colorectal cancer, and Unresectable or advanced hepatocellular carcinoma

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

15/07/2025 The first patient has been enrolled in the Phase 3 HARMONi-GI6 trial of ivonescimab + chemo in CRC ( Ref ) The first patient...

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab...

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

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

24/04/2025 Ivonescimab Plus Chemotherapy Shows Statistically Significant Superiority Over Tislelizumab in First-Line Treatment of...