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Laguna Biotherapeutics Reports the US FDA IND Clearance for LGNA-100 to Treat High-Risk Pediatric Leukemias

Shots: The US FDA has granted IND clearance to LGNA-100, Laguna Biotherapeutics’ lead clinical candidate from the QUAIL platform, to initiate the P-I trial The P-I single ascending dose study will assess safety, tolerability, & mechanism of LGNA-100 via IV infusion in pediatric & young adults with high-risk acute leukemias & MDS post αβ-depleted HSCT…
2 days ago

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Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)

Shots: The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC) HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions Cetuximab is an anti-EGFR monoclonal…
April 15, 2026

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NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis

Shots: The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC) The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…
February 20, 2026

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CStone Receives the US FDA IND Clearance to Initiate P-II Trial of CS2009 in Advanced Solid Tumors

Shots: The US FDA has granted IND Clearance to initiate P-II trial of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) in pts with advanced solid tumors CS2009 is being evaluated in a P-II trial (currently enrolling) across Australia & China, spanning 15 cohorts to evaluate monotx. & combination regimens in 9 solid tumors, incl. NSCLC, colorectal cancer, TNBC,…
February 17, 2026

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Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Shots: The US FDA has cleared Novaliq’s IND application for NOV05, enabling initiation of the EYETAC P-II clinical study in pts with non-infectious anterior uveitis (NIAU) The EYETAC P-II study will be conducted in the US and is expected to begin in Q1’26, evaluating the safety, tolerability, and dose-dependent anti-inflammatory effects of NOV05 NOV05 is…
January 27, 2026

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D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
January 19, 2026

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