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

01/10/2025 The US FDA accepted the sBLA for Enhertu® followed by THP for HER2+ve early-stage Breast Cancer ( Ref ) Daiichi Sankyo and...

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction ( Ref ) Genmab and Merus announced a transaction...

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer ( Ref ) The US FDA...

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

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC ( Ref ) Nuvalent, Inc has completed its NDA...

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

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer ( Ref ) The US FDA granted...

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

August 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Boehringer Ingelheim 's zongertinib (kinase...

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

23/07/2025 Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA...

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

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...