23/07/2025 Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation (Ref) The European Commission approved Roche's inavolisib (Itovebi; PIK3CA inhibitor) + palbociclib + fulvestrant for the treatment of adult patients with PIK3CA-mutated, ER+ve, HER2-ve, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment The approval is bas

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer (Ref) The US FDA granted Priority Review to Johnson & Johnson's NDA filed for TAR-200 (intravesical gemcitabine releasing system) for the treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The filing was based on results from the Phase 2b SunRISe-1 trial which demonstrated a CR of 82.4% wi

11/07/2025 Cel-Sci to partner with a leading Saudi Arabian pharma company for Multikine in the Tx of Head & Neck Cancer (Ref) Cel-Sci Corporation announced an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia The Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation appl

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC (Ref) The US FDA approved AstraZeneca and Daiichi's datopotamab deruxtecan (Datroway; TROP2 ADC) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. The indication is approved under accelerated approval based on ORR and DoR results from a subgroup analysis of