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News about "New Drug Application (NDA) "
Bayer Wins US FDA Priority Review for Asundexian Stroke Prevention Therapy
Bayer receives US Food and Drug Administration Priority Review (PR) for asundexian to reduce recurrent stroke risk after non-cardioembolic ischemic stroke or transient ischemic attack, supported by positive phase 3 OCEANIC-STROKE trial results.
New Drug Application (NDA) | 20/05/2026 | By News Bureau
Novo Nordisk Seeks FDA Approval for CagriSema Weight-Loss Therapy
CagriSema 2.4 mg/2.4 mg is an investigational once-weekly injectable combining cagrilintide and semaglutide to target complementary obesity pathways. In the REDEFINE 1 phase III trial, patients with obesity or overweight achieved an average weight loss of 23 percent, reinforcing the company’s ongoing focus on innovation in obesity treatment.
New Drug Application (NDA) | 19/12/2025 | By News Bureau | 221
US FDA Accepts Gadoquatrane for Review: Bayer
Bayer has submitted New Drug Application (NDA) for low dose contrast agent gadoquatrane to seek approval for contrast-enhanced Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) and other body regions for adults and paediatric patients including neonates.
New Drug Application (NDA) | 27/08/2025 | By Dineshwori | 256
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