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News about "Orphan Drug Designation "
Diamyd Medical Advances Type I Diabetes Phase III Efficacy Readout by Nine Months
Diamyd Medical has aligned with the US FDA to accelerate the primary efficacy readout of its Phase 3 DIAGNODE-III trial in type 1 diabetes from 24 to 15 months, enabling results to be available nine months earlier than previously planned.
Orphan Drug Designation | 30/12/2025 | By News Bureau
SN Bioscience's SNB-101 Secures FDA Orphan Drug Designation for Gastric Cancer
SNB-101 is a polymer nanoparticle–based anticancer drug that uses SN-38, a highly potent but extremely insoluble active pharmaceutical ingredient.
Orphan Drug Designation | 29/12/2025 | By Abha
Moleculin Launches Grant-Funded Study of Annamycin for Pancreatic Cancer at UNC-Chapel Hill
Moleculin has initiated a grant-funded preclinical programme at the University of North Carolina at Chapel Hill to evaluate Annamycin in pancreatic cancer, including its use alongside novel therapeutic agents and modalities. Early studies suggest Annamycin may effectively target key drivers of the disease.
Orphan Drug Designation | 15/11/2025 | By Dineshwori | 108
Shanghai MicuRx's MRX-5 Receives FDA Orphan Drug Designation for NTM Infections
MRX-5 is a novel benzoxazole antibiotic developed for treating mycobacteria infections, particularly infections caused by non-tuberculous mycobacteria (NTM).
Orphan Drug Designation | 03/01/2025 | By Abha | 390
Vanda Pharmaceuticals Receives Orphan Drug Designation Granted for VGT-1849A
VGT-1849A is a novel ASO treatment candidate for PV and other JAK2-driven hematologic malignancies.
Orphan Drug Designation | 21/12/2024 | By Aishwarya | 812
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