15/06/2026 Midstage Pancreatic Cancer Study Fails to Meet Primary Endpoint but Will Advance to Phase 3 FDA accepts ozekibart BLA, setting April 2027 PDUFA for conventional Chondrosarcoma Halia Therapeutics Secures FDA Fast Track Designation for Ofirnoflast in Lower-Risk MDS Menarini Group's Phase 3 SENTRY trial met its first co-primary endpoint, with the selinexor + ruxolitinib combination achieving significant improvement in spleen volume reduction (SVR35) vs ruxolitinib alo

02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma (Ref) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the p

29/01/2026 Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia (Ref) The US FDA granted the Fast Track designation to Quetzal Therapeutics' QTX-2

30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies (Ref) The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (off-the-shelf drug product that generates CD19-directed CAR T cells in vivo) for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of

September 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co/MSD’s Keytruda Qlex (subcutaneous injection of pembrolizumab and berahyaluronidase alfa) in adults across most solid tumor indications for Keytruda. (Ref 1) ❓ How is this SC injection positioned against other approved SC anti-PD(L)1s? 🎯 Japan’s Ministry of Health, Labour and Welfare approved Novocure's Optune Lua (tumor treating fields) for concurrent use with PD-1/PD-L1 inhibitors for the Tx of adu

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref) The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons: The Ph1

📢 The U.S. FDA launched a new program - the Commissioner’s National Priority Voucher (CNPV) - to shorten review timelines from 10-12 months to 1-2 months following a sponsor’s final drug application submission. ⭐ The vouchers will be given only to the companies that are aligned with U.S. national priorities. ⭐ Attached is the slide deck with additional details. 📧 For further details, please write to us at support@oncofocus.com. 🌐 References: 1) https://www.fda.gov/news-eve