Managed Healthcare Executive

Novo Nordisk Resubmits BLA for Once-Weekly Insulin for Type 2 Diabetes

If approved, Awiqli would become the first once-weekly basal insulin available in the United States for adults with Type 2 ...
PharmExec

Novo Nordisk Resubmits Biologics License Application to FDA for Awiqli

Novo Nordisk aims to revolutionize diabetes care with Awiqli, a potential once-weekly insulin, resubmitted for FDA approval ...
Nasdaq

Fractyl Health Submits Clinical Trial Application for First-in-Human Study of RJVA-001 Gene Therapy for Type 2 Diabetes and Obesity

Fractyl Health announced a first-in-human trial for RJVA-001, targeting T2D and obesity, pending regulatory approval by 2026. Fractyl Health, Inc. has announced the submission of the first module of ...
Business Wire

Bayer Submits Regulatory Applications for Investigational Drug Finerenone in the U.S. and the EU for Patients with Chronic Kidney Disease and Type 2 Diabetes

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to ...