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Home » Topics » Regulatory, BioWorld Science

Regulatory, BioWorld Science
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3D rendering of an antibody drug conjugate
Immuno-oncology

Innocare’s ICP-B794 gains IND clearance in China

July 4, 2025
No Comments
Innocare Pharma Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of the B7-H3 targeted antibody-drug conjugate.
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Multiple myeloma illustration
Immuno-oncology

Brightpath’s BP-2202 designated orphan drug for multiple myeloma

July 4, 2025
No Comments
Brightpath Biotherapeutics Co. Ltd.’s iPS cell-derived BCMA CAR-natural killer T cell therapy candidate has been awarded orphan drug designation by the FDA for the treatment of multiple myeloma.
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DNA and cancer cells
Cancer

Hemispherian’s GLIX-1 awarded US orphan drug designation for malignant glioma

July 1, 2025
No Comments
GLIX-1 is a first-in-class small-molecule therapeutic targeting DNA repair vulnerabilities in cancer cells.
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Heart and DNA
Cardiovascular

FDA clears Rocket Pharmaceuticals’ IND for gene therapy candidate

June 30, 2025
No Comments
The U.S. FDA has cleared Rocket Pharmaceuticals Inc.’s IND application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-associated dilated cardiomyopathy (BAG3-DCM), a severe form of heart failure.
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3D illustration showing presence of tumor inside prostate gland
Cancer

Archeus gains IND clearance for ART-101 in prostate cancer

June 23, 2025
No Comments
Archeus Technologies Inc. has obtained IND clearance from the FDA for ART-101, a novel receptor-based targeting small molecule for the imaging and treatment of prostate cancer.
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3d rendering of bispecific antibodies
Cardiovascular

Diagonal Therapeutics’ DIAG-723 designated orphan drug for hereditary hemorrhagic telangiectasia

June 19, 2025
No Comments
Diagonal Therapeutics Inc.’s DIAG-723 has been awarded orphan drug designation by the FDA for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the EMA has provided a positive opinion for orphan drug designation, confirming that DIAG-723 meets the criteria for designation as an orphan drug in the E.U.
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Illustration of cancer tumor on pancreas
Immuno-oncology

Medicovestor’s Adobind MC-001 awarded US orphan drug designation

June 18, 2025
No Comments
Medicovestor Inc.’s Adobind MC-001 has been awarded orphan drug designation by the FDA for the treatment of pancreatic cancer. Adobind MC-001 is a chemoimmunotherapy antibody-drug conjugate that integrates proprietary enhancements to antibody structure, payload delivery and tumor engagement.
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Tape measure, apple on scale
Endocrine/metabolic

MBX Biosciences files IND application for MBX-4291 for obesity

June 17, 2025
No Comments
MBX Biosciences Inc. has submitted an IND application to the FDA for MBX-4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.
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Neurology/psychiatric

Centessa’s OX2R agonist ORX-142 gains IND clearance

June 17, 2025
No Comments
Centessa Pharmaceuticals plc has obtained IND clearance from the FDA to initiate a phase I study of ORX-142 in healthy volunteers. ORX-142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and neurodegenerative disorders.
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CAR T illustration
Immuno-oncology

Myrio’s PHOX2B PC-CAR T for neuroblastoma gains IND clearance

June 16, 2025
No Comments
Myrio Therapeutics Pty Ltd. is set to advance lead product PHOX2B PC-CAR T (PHOX2B peptide-centric chimeric antigen receptor autologous T cells) into clinical trials for relapsed neuroblastoma following IND clearance by the FDA. The first patient will be enrolled around mid-year.
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