News about "clinical development "

Tolerance Bio Licenses Anti-IL-33 Antibody TLB-33 from Tanabe Pharma

Tolerance Bio plans to advance TLB-33 into Phase 2 development to evaluate its potential in preserving thymic function and supporting immune resilience.

Clinical Development | 29/09/2026 | By News Bureau

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.

Clinical Development | 17/09/2026 | By News Bureau

Rezubio Advances RZ-520 Into Phase 1 Trial Following FDA and NMPA Clearances

Rezubio has dosed the first cohort in a Phase 1 trial evaluating RZ-520, an investigational inhaled therapy for chronic respiratory diseases.

Clinical Development | 08/09/2026 | 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.

Clinical Development | 07/09/2026 | By News Bureau

Genprex Selects Andelyn Biosciences for Scale-Up Manufacturing of Diabetes Gene Therapy

Genprex’s gene therapy candidate aims to restore insulin-producing function in diabetes by delivering Pdx1 and MafA genes to the pancreas using an AAV vector.

Clinical Development | 03/09/2026 | By Akanki

MedPharm Becomes First Olink Certified Service Provider in the Carolinas

MedPharm has become an Olink Certified Service Provider, adding multiplex proteomic analysis to its human-relevant research capabilities and becoming the first Olink CSP in the Carolinas.

Clinical Development | 24/08/2026 | By News Bureau |  123

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.

Clinical Development | 19/08/2026 | By News Bureau

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.

Clinical Development | 10/08/2026 | By News Bureau |  172

Sanofi to not Submit Amlitelimab in Atopic Dermatitis for Global Regulatory Reviews

Sanofi will not seek global regulatory approval for amlitelimab in Atopic Dermatitis (AD) after efficacy and safety data did not support further development.

Clinical Development | 27/07/2026 | By News Bureau |  155

Ascletis Selects Oral ASC30-ASC48 Fixed-Dose Combination for Clinical Development in Obesity

Ascletis Pharma has selected its ASC30-ASC48 fixed-dose combination for clinical development as a once-daily oral therapy for obesity. The dual-target GLP-1R/GIPR candidate demonstrated encouraging preclinical efficacy, with an IND submission to the US FDA planned for Q4 2026.

Clinical Development | 17/07/2026 | By News Bureau |  222