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News about "New Drug Application (NDA) "
Zealand Pharma Signs USD 100 Million Royalty Deal with Royalty Pharma for Rusfertide
Zealand Pharma will receive USD 100 million from Royalty Pharma for its rusfertide economic interests, unlocking value from royalty rights for strategic investments.
New Drug Application (NDA) | 13/08/2026 | By News Bureau | 123
CureGene Doses First Patient in Pivotal US Trial of Evategrel
CureGene achieves first participant dosed in US pivotal trial for Evategrel (CG-0255), a best-in-class antiplatelet drug, accelerating global commercialisation.
New Drug Application (NDA) | 23/06/2026 | By News Bureau | 233
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 | 127
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 | 262
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 | 280
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