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BioWorld - Sunday, December 28, 2025
Home » Topics » FDA, BioWorld Science

FDA, BioWorld Science
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Endocrine/Metabolic

Abliva’s NV-354 awarded US orphan drug designation for mitochondrial disease

April 18, 2023
Abliva AB’s NV-354 has been granted orphan drug designation by the FDA for the treatment of mitochondrial disease.
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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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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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Cancer

Tango's CoREST complex inhibitor TNG-260 cleared to enter clinic for STK11-mutant cancers

April 4, 2023
Tango Therapeutics Inc. has received FDA clearance of its IND application for TNG-260.
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Lung cancer illustration
Immuno-oncology

CSPC Pharmaceutical’s antibody-drug conjugate CPO-301 cleared to enter clinic in US for lung cancer

April 3, 2023
CSPC Pharmaceutical Group Ltd. has received FDA clearance of its IND for a phase I trial of its antibody-drug conjugate CPO-301 for the treatment of advanced lung cancer with alterations in the EGFR gene or EGFR over-expression.
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CAR T cell with implanted gene strand
Musculoskeletal

Cabaletta’s IND for CABA-201 for SLE receives FDA clearance

April 3, 2023
Cabaletta Bio Inc.’s IND application for CABA-201, a 4-1BB-containing fully human CD19-chimeric...
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Pregnant woman
Obstetrics

Comanche’s siRNA therapy CBP-4888 cleared by FDA to enter clinic for pre-eclampsia

March 31, 2023
Comanche Biopharma Corp. has received IND clearance from the FDA to conduct a first-in-human study of CBP-4888, its novel, small interfering ribonucleic acid (siRNA) therapy to treat pre-eclampsia.
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Immune

Pathovax receives IND clearance for phase I study of HPV16 RG1-VLP

March 30, 2023
Pathovax LLC is developing a universally preventative human papillomavirus (HPV)...
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Skin, tissue layer illustration
Dermatologic

Eloxx files IND application for ZKN-013 to treat recessive dystrophic epidermolysis bullosa

March 29, 2023
Eloxx Pharmaceuticals Inc. has filed an IND application with the FDA for ZKN-013 for the...
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