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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 | 211
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 | 115
The FDA lifted the clinical hold on Intellia’s phase III MAGNITUDE trial evaluating CRISPR-based therapy nex-z for transthyretin amyloidosis with cardiomyopathy, enabling the company to resume patient enrollment with enhanced safety measures.
Investigational New Drug | 05/03/2026 | By News Bureau | 152
Frontier Biotechnologies Inc. Signs USD 1 Billion siRNA Licensing Deal with GSK
Frontier Biotech has granted GSK exclusive global rights to two siRNA drug candidates in a deal worth up to USD 1 billion, strengthening its international expansion and immunology pipeline focus.
Investigational New Drug | 25/02/2026 | By News Bureau | 223
TuHURA Biosciences Files IND for TBS-2025 in Relapsed/Refractory mutNPM1 AML
TuHURA Biosciences has filed an IND with the FDA to evaluate its VISTA-targeting antibody TBS-2025 in combination with a menin inhibitor for relapsed/refractory mutNPM1 AML.
Investigational New Drug | 20/02/2026 | By News Bureau | 210
CStone's CS2009 Secures U.S. FDA IND Clearance for Phase II Trial in Advanced Solid Tumours
CStone Pharmaceuticals has received U.S. FDA IND clearance to begin a Phase II trial of its trispecific antibody CS2009 for advanced solid tumours, advancing its global immunotherapy development programme.
Investigational New Drug | 16/02/2026 | By News Bureau | 135
ArkBio Receives US FDA IND Clearance for AK3280 in Idiopathic Pulmonary Fibrosis
FDA clears ArkBio’s IND application for AK3280, enabling a Phase II proof-of-concept trial in the US to evaluate the novel anti-fibrotic therapy in patients with idiopathic pulmonary fibrosis.
Investigational New Drug | 12/02/2026 | By News Bureau | 121
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 | 224
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 | 200
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 | 195
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