Last edition
News about "Investigational New Drug "
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
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 | 311
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
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
Qnovia Secures Global License for Novel Antimicrobial Peptide to Combat Drug-Resistant Infections
Qnovia has obtained worldwide exclusive rights from the University of Virginia to develop and commercialise the D8 antimicrobial peptide, a novel therapy designed to target multidrug-resistant bacterial infections through a unique mechanism.
Investigational New Drug | 31/07/2026 | By News Bureau
INTENT Biologics Secures FDA Breakthrough Therapy Tag for Diabetic Foot Ulcer Treatment Candidate
INTENT Biologics' PEP Biologic receives FDA Breakthrough Therapy designation for diabetic foot ulcers, accelerating development of its first-in-class exosome-based regenerative treatment aimed at improving healing outcomes in chronic wounds.
Investigational New Drug | 03/07/2026 | By News Bureau | 233
Shanghai UniXell Biotechnology. has received US Food and Drug Administration IND clearance for UX-GIP001, marking the first iPSC-derived allogeneic cell therapy to enter clinical trials for Epilepsy in the US.
Investigational New Drug | 17/03/2026 | By News Bureau | 261
National Medical Products Administration approves IND application for HBM7575/SKB575, a long-acting bispecific antibody developed by Harbour BioMed and Kelun-Biotech for treating atopic dermatitis.
Investigational New Drug | 10/03/2026 | By News Bureau | 164
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy