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BioWorld - Wednesday, December 24, 2025
Home » Topics » Regulatory » IND

IND
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Immuno-oncology

Harbour’s bispecific antibody HBM-9027 cleared to enter clinic in US for solid tumors

Jan. 24, 2024
Harbour Biomed Ltd. has obtained FDA clearance of its IND application to initiate a first-in-human...
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Neurology/Psychiatric

Vanda receives IND clearance for ASO for Charcot-Marie-Tooth disease type 2S

Jan. 24, 2024
Vanda Pharmaceuticals Inc. has announced FDA approval of its IND application to evaluate VCA...
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Neurology/Psychiatric

Juvena’s JUV-161 awarded US orphan drug designation for myotonic dystrophy type 1

Jan. 24, 2024
The FDA has awarded orphan drug designation to Juvena Therapeutics Inc.’s JUV-161, an...
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3d illustration of ovarian cancer
Immuno-oncology

NK Celltech announces US IND clearance for NK cell therapy NK-010

Jan. 23, 2024
NK Celltech Co. Ltd. has announced FDA clearance for a clinical trial of NK-010, a nongenetically modified allogeneic peripheral blood natural killer (NK) cell drug.
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Immuno-oncology

Strand’s STX-001 receives IND clearance from FDA to treat solid tumors

Jan. 23, 2024
Strand Therapeutics Inc. has received IND clearance from the FDA to initiate a first-in-human phase I trial of STX-001 as a new approach for the treatment of solid tumors.
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Ischemic stroke
Neurology/Psychiatric

Aruna’s AB-126 cleared to enter clinic for acute ischemic stroke

Jan. 17, 2024
Aruna Bio Inc. has gained FDA clearance for its IND application for AB-126, enabling initiation of a phase Ib/IIa trial in acute ischemic stroke.
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3D Rendering of tumor microenvironment
Immuno-oncology

CSPC’s bispecific fusion protein drug JMT-106 gains US IND clearance for GPC3-positive solid tumors

Jan. 16, 2024
CSPC Pharmaceutical Group Ltd. has announced FDA approval of an IND application for JMT-106, a bispecific fusion protein drug, for glypican-3 (GPC3)-positive solid tumors.
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Art concept for monoclonal antibodies
Immuno-oncology

Corbus gains IND clearance for anti-αvβ8 monoclonal antibody

Jan. 10, 2024
Corbus Pharmaceuticals Holdings Inc. has obtained FDA clearance of its IND application for CRB-601, a TGF-β-blocking monoclonal antibody targeting the integrin αvβ8. Enrollment in a first-in-human phase I study will open in the first half of this year.
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3D illustration demonstrating CAR T therapy
Immuno-oncology

Sana’s hypoimmune CD22-directed allogeneic CAR T-cell therapy gains IND clearance

Jan. 8, 2024
Sana Biotechnology Inc. has obtained FDA clearance of its IND application to conduct a study of SC-262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed chimeric antigen receptor (CAR) T therapy.
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Skin, tissue layer illustration
Dermatologic

OQL-025 cleared to enter clinic for EGFR inhibitor-induced rash

Jan. 5, 2024
Onquality Pharmaceuticals LLC has obtained IND clearance from the FDA for OQL-025 to treat epidermal growth factor receptor (EGFR) inhibitor-induced acneiform rash, a common toxicity affecting patients treated with EGFR inhibitor therapy for various cancers.
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