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Oncology Updates - Key Oncology News
July 5th Week, 2026 Regulatory Events 🎯 Marketing Authorization Application (MAA) for Philogen S.p.A. and SUN PHARMA’s daromun (Nidlegy™; L19IL2 and L19TNF combination) for the neoadjuvant Tx of locally advanced, fully resectable melanoma was resubmitted to the EMA (Ref) ❓ What are the clinical benchmarks for resectable melanoma Tx in the EU? 🎯 Replimune announced a favorable outcome from the US FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) meetin

Oncofocus Team
Aug 132 min read
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Oncology Updates - Key Oncology News
February 1st Week, 2026 Regulatory Events 🎯 The US FDA approved an update to Gilead Sciences' axicabtagene ciloleucel (anti-CD19 CAR-T) prescribing information removing the previous “Limitations of Use” in patients with relapsed/refractory primary central nervous system lymphoma (Ref 1) ❓ How would this decision alter Yescarta’s positioning in the market landscape? 🎯 AstraZeneca and Daiichi Sankyo US’ sBLA for datopotamab deruxtecan (TROP2 ADC) was accepted and granted a Pr

Oncofocus Team
Feb 102 min read
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