Diamyd Medical, a Sweden-based company that develops precision medicine therapies for Type 1 Diabetes, announced on Monday that the US Food and Drug Administration (FDA) has withdrawn the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, assessing the safety and efficacy of the precision medicine and antigen-specific immunotherapy Diamyd in individuals recently diagnosed with type 1 diabetes.
Subsequent to the decision from the FDA, DIAGNODE-3 is approved to commence in the United States.
The FDA issued a partial clinical hold on the trial in September 2021, halting its commencement in the US. The company is to immediately resume the process of interacting with clinical sites and institutional review boards with the intention of including US clinical sites in the trial. The trial has been approved and is actively hiring patients in eight European countries.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial