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BioWorld - Thursday, April 16, 2026
Home » Topics » FDA, BioWorld Science

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Cancer cells
Immuno-oncology

Cytomx receives IND clearances for CX-2051 and CX-801

Jan. 25, 2024
Cytomx Therapeutics Inc. has received clearances from the FDA for IND applications for two conditionally activated Probody therapeutics.
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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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Cancer cell targeted in crosshairs
Immuno-oncology

ROR1-targeting PBA-0405 cleared to enter phase 0 trial for solid tumors

Jan. 17, 2024
Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.
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Neurology/Psychiatric

Solid Biosciences’ SGT-003 granted orphan drug designation for Duchenne muscular dystrophy

Jan. 17, 2024
Solid Biosciences Inc.’s SGT-003 has been granted orphan drug designation by the FDA. The company’s next-generation Duchenne muscular dystrophy gene therapy candidate was also granted fast track designation last month.
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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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