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

14/08/2025 Halda's HLD-0915 received the Fast Track Designation from the US FDA for mCRPC ( Ref ) The US FDA granted the Fast Track...

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

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC ( Ref ) The European Commission granted marketing...

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

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA ( Ref ) The US FDA granted the...

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