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Delonix Bioworks Secures NMPA IND Clearance for MenB Vaccine Candidate DX-104
China grants IND approval for DX-104 after Australia CTN clearance, paving the way for Phase I trials of Delonix’s engineered Group B meningococcal vaccine.
Investigational New Drug | 09/02/2026 | By News Bureau
FDA Accepts IND for Affinia's AFTX-201 Gene Therapy in BAG3 Dilated Cardiomyopathy
Affinia Therapeutics receives FDA clearance to begin clinical testing of AFTX-201, a next-generation AAV gene therapy for BAG3-associated dilated cardiomyopathy, with Phase 1/2 UPBEAT trial set to begin in 2026.
Investigational New Drug | 09/02/2026 | By News Bureau
PharmaResearch Wins FDA Clearance for Phase-I Trial of PRD-101
PRD-101 is a next-generation nano anti-cancer drug candidate formulated using nucleotide fragments produced through PharmaResearch's proprietary DOT (DNA Optimising Technology).
Investigational New Drug | 07/02/2026 | By News Bureau
Trace Biosciences Secures FDA IND Clearance for First Nerve-Specific Fluorescent Imaging Agent
FDA clears IND application for LGW16-03, enabling Trace Biosciences to begin first-in-human trials of its nerve-targeted imaging agent designed to reduce accidental nerve injuries during surgery.
Investigational New Drug | 02/02/2026 | By News Bureau
WuXi Biologics, Sinorda Biomedicine Partner to Advance Bispecific Antibody for Autoimmune Diseases
WuXi Biologics and Sinorda Biomedicine collaborate to accelerate development of SND006, a novel bispecific antibody targeting inflammatory bowel disease and autoimmune disorders.
Investigational New Drug | 29/01/2026 | By News Bureau
D3 Bio Secures FDA IND Clearance for Two Oncology Programmes
The US FDA has cleared two Investigational New Drug (IND) applications from D3 Bio, paving the way for a phase I clinical trial of D3S-003 and a phase II combination study evaluating elisrasib (D3S-001) with D3S-002, marking a key step forward in the company’s oncology development pipeline.
Investigational New Drug | 23/01/2026 | By News Bureau
Insilico Medicine and Hygtia Therapeutics have entered a co-development deal for ISM8969, an AI-designed, brain-penetrant NLRP3 inhibitor, with milestone payments of up to USD 66 million.
Investigational New Drug | 21/01/2026 | By News Bureau | 141
GC Biopharma Wins IND Approval in Korea for Phase I COVID-19 mRNA Vaccine Trial
GC Biopharma has received IND approval in Korea to initiate a Phase I clinical trial of its COVID-19 mRNA vaccine, marking a key step in advancing its mRNA platform, with plans to submit a Phase II IND in the second half of 2026.
Investigational New Drug | 24/12/2025 | By News Bureau | 145
CASI Pharmaceuticals Plans to Submit IND Application For CID-103
CASI Pharmaceuticals, Inc. has planned to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for CID-103 for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients by the end of 2024.
Investigational New Drug | 28/06/2024 | By Aishwarya | 589
Aptamer Sciences Files IND Application for Phase 1 Clinical Trial of AST-201
Aptamer Sciences Inc. has filed for an Investigational New Drug (IND) application for the phase 1 clinical trial of AST-201 with the Korean Ministry of Food and Drug Safety
Investigational New Drug | 26/03/2024 | By Manvi | 886
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