Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)

Shots: The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…

ByDipanshu DixitDecember 19, 2025

Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Shots: Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative options Approval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…

ByRidhi RastogiAugust 20, 2025

Mabwell Reports First Patient Dosing in P-I Trial of Bulumtatug Fuvedotin for Triple-Negative Breast Cancer (TNBC) in the US

Shots: Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP Bulumtatug Fuvedotin, a Nectin-4–targeting…

ByRidhi RastogiAugust 13, 2025

Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)

Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Mabwell Reports First Patient Dosing in P-I Trial of Bulumtatug Fuvedotin for Triple-Negative Breast Cancer (TNBC) in the US

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