NG Biotech announces FDA approval for diagnostic assays
NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.
19 February 2026
19 February 2026
NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.
MSD will integrate clinical insights and genomic datasets from Mayo Clinic Platform, aggregating data in a secure environment.
The designation supports priority engagement with the FDA as Portal Diabetes advances clinical trials and regulatory submissions.
The therapy dosing provides clinical outcomes consistent with those of the earlier approved bi-weekly subcutaneous regimen.
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