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October 27, 2025
Article
FDA approves Omvoh (mirikizumab-mrkz) for monthly maintenance of ulcerative colitis, simplifying treatment for patients with this chronic condition.
The phase 3 ZENITH trial showed sotatercept’s superiority over placebo in reducing morbidity and mortality outcomes in adults with WHO FC III or IV PAH.
October 22, 2025
FDA launches the Commissioner’s National Priority Voucher program, expediting drug reviews for critical health needs.
October 20, 2025
This approval represents an alternative method for approaching this undertreated disease, shortening recovery while minimizing invasiveness.
Rybelsus marks the first oral GLP-1 for major adverse cardiovascular events in adult patients with T2D, opening a new cardiovascular treatment pathway.
The decision is supported by positive results from the phase 2 NOBILITY and phase 3 REGENCY studies.
October 17, 2025
Tezepelumab is the first TSLP-targeting biologic to be approved for chronic rhinosinusitis with nasal poylps.
The FDA approved expanded indications for adalimumab-aaty (Yuflyma) and its unbranded version to include the treatment of adolescent HS and pediatric UV.
October 16, 2025
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Santreva-ATK, the first wire-free endovascular revascularization catheter for crossing chronic total occlusions, is expected to begin sale in October 2025.
October 15, 2025
The therapy is currently approved in almost 50 countries under the name Trimbow.
