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BioWorld - Wednesday, July 15, 2026
Home » Topics » Regulatory » IND

IND
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Woman receiving chemotherapy
Substance Use & Poisoning

Onquality receives IND clearance for OQL-036 for capecitabine-induced hand-foot syndrome

May 2, 2023
Onquality Pharmaceuticals LLC has received FDA clearance of its IND application for OQL-036, a potential prophylactic treatment for capecitabine-induced hand-foot syndrome (HFS).
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Eye and DNA
Ocular

Atsena’s ATSN-201 receives IND clearance to enter clinic for X-linked retinoschisis

May 2, 2023
Atsena Therapeutics Inc.’s IND application for ATSN-201 has been cleared by the FDA enabling the company to initiate a phase I/II trial in patients with X-linked retinoschisis (XLRS) caused by pathogenic or likely pathogenic mutations in RS1.
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Immuno-oncology

Sirpant’s macrophage therapy Sirpant-M cleared by FDA to enter first-in-human study for NHL

May 2, 2023
Sirpant Immunotherapeutics Inc. has received...
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Cancer

Biomea’s third-generation covalent FLT3 inhibitor cleared to enter clinic in US for acute leukemia

May 2, 2023
Biomea Fusion Inc. has received FDA clearance...
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Virus and vaccine illustration
Immune

Rnaimmune’s SARS-CoV-2 vaccine booster candidate RV-1730 cleared to enter clinic in US

April 28, 2023
Rnaimmune Inc., a nonwholly owned subsidiary of Sirnaomics Ltd., has received clearance from the FDA for its IND application to conduct a phase I trial for RV-1730, a SARS-CoV-2 vaccine booster candidate.
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The epidermal growth factor receptor in the inactive (left) and active (right) form.
Cancer

Bridge Biotherapeutics’ fourth-generation EGFR TKI BBT-207 cleared to enter clinic in US for advanced NSCLC

April 24, 2023
Bridge Biotherapeutics Inc. has received FDA clearance to proceed with a first-in-human study of BBT-207, a potential broad-spectrum fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of non-small-cell lung cancer (NSCLC).
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Non-Hodgkin lymphoma cells in the blood flow
Cancer

Hanchorbio’s HCB-101 cleared by FDA to enter clinic for advanced solid tumors and NHL

April 18, 2023
Hanchorbio Inc. has received IND clearance by the FDA to initiate a clinical trial of HCB-101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma (NHL).
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Neurology/Psychiatric

Promis Neurosciences submits IND in US to study PMN-310 in Alzheimer’s disease

April 11, 2023
Promis Neurosciences Inc. has submitted an IND application to the FDA for PMN-310 for the treatment of Alzheimer’s disease. PMN-310 is a monoclonal antibody designed to be highly selective for toxic oligomers of amyloid-β (Aβ) that are believed to be a major driver of AD, as opposed to monomers or plaque.
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Infection

Grand Pharmaceutical’s APAD cleared to enter clinic in China for sepsis

April 6, 2023
Grand Pharmaceutical Group Ltd. has received...
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Ocular

Perfuse’s PER-001 intravitreal implant receives FDA clearance for first-in-human study in glaucoma

April 5, 2023
Perfuse Therapeutics Inc. has received FDA approval of its IND application for a first-in-human phase I/IIa study of PER-001 intravitreal implant in patients with glaucoma.
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