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BioWorld - Sunday, April 12, 2026
Home » Topics » Regulatory » IND

IND
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Gastrointestinal system with ulcerative colitis.
Gastrointestinal

Asieris receives FDA clearance to enter clinic with APL-1401 for ulcerative colitis

Nov. 11, 2022
Asieris Pharmaceuticals Co. Ltd. has received FDA clearance of its IND for APL-1401 for the treatment of moderate to severely active ulcerative colitis.
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Endocrine/Metabolic

FDA clears allogenic cellular therapy Allostem to enter clinic for type 1 diabetes

Nov. 4, 2022
Creative Medical Technology Holdings Inc. has received FDA clearance of its IND application for a clinical trial of Allostem in type 1 diabetes.
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Dermatologic

Brexogen receives FDA clearance for phase I trial of exosome-based therapy for atopic dermatitis

Nov. 3, 2022
The FDA has cleared Brexogen Inc. to initiate a phase I trial of BRE-AD01, an exosome-based therapy for atopic dermatitis.
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Endocrine/Metabolic

Eccogene cleared by FDA to begin phase I study of oral GLP-1 receptor agonist

Nov. 3, 2022
Eccogene (Shanghai) Co. Ltd. has received FDA clearance to begin a phase I study of its glucagon-like peptide 1 (GLP-1) receptor agonist ECC-5004 for type 2 diabetes.
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Cancer cells
Immuno-oncology

Turnstone receives IND clearance for phase I trial of TIDAL-01 for solid tumors

Nov. 2, 2022
Turnstone Biologics Corp. has received IND clearance from the FDA for the company's lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01.
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Cancer

Abbisko cleared to enter clinic with FGFR inhibitor ABSK-121 for solid tumors

Nov. 2, 2022
Abbisko Therapeutics Co. Ltd. has received clearance from the FDA to initiate a phase I...
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Immune checkpoint inhibitors illustration of PD-1, CTLA-4 and PD-L1.
Immuno-oncology

FDA approves IND for bifunctional fusion protein SIM-0237

Oct. 28, 2022
Simcere Pharmaceutical Group announced that the FDA has cleared the company’s IND application for SIM-0237 for the treatment of adult patients with advanced solid tumors.
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Infection

Ascletis files IND application for ASC-10 as treatment of monkeypox virus infection

Oct. 27, 2022
Ascletis Pharma Inc. announces that the company has filed an IND application with the FDA for ASC-10, an oral antiviral drug candidate targeting viral polymerase of monkeypox virus.
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Central nervous system
Neurology/Psychiatric

FDA clears IND application and grants orphan drug designation for CE-VST01-JC

Oct. 26, 2022
Cellevolve Bio Inc. announced that the FDA has cleared its IND application for CE-VST01-JC, an allogeneic, off-the-shelf, JC-specific T-cell therapy (JC-VST) targeting JC polyoma virus (JCV), being studied for the treatment of progressive multifocal leukoencephalopathy (PML).
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Illustration of neuromuscular junction in myasthenia gravis
Neurology/Psychiatric

Cour Pharmaceuticals set to advance CNP-106 for myasthenia gravis

Oct. 26, 2022
Cour Pharmaceuticals Inc. announced that the FDA has cleared an IND application to initiate a phase Ib/IIa proof-of-concept study of its...
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