24/11/2025 Avenzo Therapeutics' AVZO-103 received the FDA fast track designation for metastatic urothelial cancer ( Ref ) The US FDA granted the fast track desingation to Avenzo Therapeutics' AVZO-103 (Nectin4/TROP2 bispecific antibody-drug conjugate) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer, Avenzo Therapeutics: “ Rece

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL ( Ref ) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.  The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmac

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC ( Ref ) The US FDA approved Regeneron...

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

27/08/2025 BeOne Medicines' perioperative tislelizumab regimen received approval from the EC for resectable NSCLC ( Ref ) The EC approved...

26/08/2025 Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer ( Ref ) The US FDA...

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

21/08/2025 In a $350M deal, Kite to acquire Interius BioTherapeutics ( Ref ) Kite (a Gilead Company) entered into a definitive agreement...