News about "Investigational New Drug "

US FDA Finalises Expedited IND Pilot to Accelerate First-in-Human Clinical Trials

The US FDA has finalised the Expedited IND Pilot, which will test a rolling review model and greater coordination to support faster initiation of first-in-human clinical trials.

Investigational New Drug | 17/09/2026 | By News Bureau

Alebund Receives US FDA IND Clearance for IgA Nephropathy Drug Candidate AP308

Alebund Pharmaceuticals has received US FDA IND clearance for AP308, an engineered recombinant IgA protease, paving the way for first-in-human clinical testing in IgA nephropathy.

Investigational New Drug | 10/09/2026 | By News Bureau |  109

Ascletis Initiates US Phase 1 Study of Oral ASC36 for Obesity

Ascletis has initiated a US Phase 1 study of ASC36, an investigational oral amylin receptor peptide agonist developed using the company’s proprietary oral peptide delivery technology.

Investigational New Drug | 09/09/2026 | By News Bureau

Acepodia Receives FDA Clearance for ACE723 ADC in Advanced Liver Cancer

Acepodia’s ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumour cells in patients with unresectable or metastatic hepatocellular carcinoma.

Investigational New Drug | 07/09/2026 | By News Bureau |  114

Harbour BioMed Secures China IND Approval for HBM7004 in Advanced Solid Tumours

NMPA clearance advances the B7H4xCD3 bispecific antibody toward clinical development, following promising preclinical efficacy and safety results and recent US FDA clearance.

Investigational New Drug | 19/08/2026 | By News Bureau

OncoC4 Doses First Patient in Phase 1 Trial of ONC-783 T-Cell Engager

OncoC4 has dosed the first patient in its Phase 1 ONC-783-001 trial, evaluating the investigational T-cell engager ONC-783, developed to target the cancer-specific neoCD24 epitope in patients with advanced solid tumours.

Investigational New Drug | 18/08/2026 | By News Bureau |  103

FDA Clears Graviton BioScience's GV101 for Phase 2 Development in Friedreich's Ataxia

Graviton BioScience has received FDA IND clearance for a new GV101 capsule formulation, paving the way for a Phase 2 trial in patients with Friedreich’s ataxia.

Investigational New Drug | 12/08/2026 | By News Bureau |  405

RiboX Wins FDA IND Clearance for First Circular RNA-Based In Vivo CAR-T Therapy

RiboX Therapeutics receives FDA IND clearance for RXIM002, an investigational circRNA-based in vivo CAR-T therapy designed to generate CD19-targeted CAR-T cells directly inside the body for autoimmune cytopenias.

Investigational New Drug | 10/08/2026 | By News Bureau |  197

Iksuda Therapeutics Secures US FDA IND Clearance for Novel ADC Candidate IKS04 in GI Cancers

Phase 1 trial to evaluate first-of-its-kind CA242-targeted antibody-drug conjugate with an innovative co-administration regimen designed to improve solid tumour penetration and therapeutic efficacy.

Investigational New Drug | 03/08/2026 | By News Bureau

US FDA Approves Teleflex's Ezplaz Freeze Dried Plasma, First Licensed FDP in the US

Teleflex has received US FDA Biologics License Application (BLA) approval for Ezplaz Freeze Dried Plasma, the first FDA-licensed freeze-dried plasma product in the United States.

Investigational New Drug | 31/07/2026 | By News Bureau |  102