Clinical Safety

Can Upadacitinib Redefine the Regulatory Path for Vitiligo?
Research & Development Can Upadacitinib Redefine the Regulatory Path for Vitiligo?

Historical failures in the vitiligo pipeline, such as the cancellation of the AC##4 trial in 2016, highlight the difficulty of establishing a global site network. The recent publication of the Viti-Up Phase 3 clinical trial results in The Lancet marks a transformative moment for dermatologic

Bioengineered Conduits Show Promise for Coronary Bypass Surgery
Research & Development Bioengineered Conduits Show Promise for Coronary Bypass Surgery

A major hurdle in cardiac surgery is the compliance mismatch between stiff artificial tubes and flexible arteries, which creates turbulent blood flow and eventual graft blockage. This fundamental discrepancy has long prevented the widespread adoption of synthetic bypass grafts, as the sudden change

VA Expands Electronic Health Record System Across Indiana
Tech & Innovation VA Expands Electronic Health Record System Across Indiana

Healthcare providers in Indianapolis and Fort Wayne are now engaging in peer-to-peer knowledge sharing to master the nuances of the new electronic health record system in real-time clinical settings. This rollout marks a defining moment for the Department of Veterans Affairs as it integrates the

VA Tests Semaglutide as a New Treatment for Alcoholism
Research & Development VA Tests Semaglutide as a New Treatment for Alcoholism

VA leadership has issued a cautionary warning against the off-label use of GLP-1 medications for alcoholism without strict medical supervision and oversight. This directive arrives just as the Charles George VA Medical Center in Asheville, North Carolina, spearheads a transformative Phase 3

How Is Global Pharmaceutical Quality Maintained at Scale?
Management & Regulatory How Is Global Pharmaceutical Quality Maintained at Scale?

Maintaining medicinal consistency across a global network requires navigating a labyrinth of geopolitical shifts and varying international regulatory expectations. The journey of a pharmaceutical product from a manufacturing plant to a patient’s local pharmacy is an intricate operation governed by

FDA Issues Second Hold on Regenxbio Hunter Syndrome Therapy
Research & Development FDA Issues Second Hold on Regenxbio Hunter Syndrome Therapy

Sponsors of CNS-directed gene therapies are now being urged to embed independent imaging review boards directly into their trial protocols to avoid similar regulatory failures. This directive follows the U.S. Food and Drug Administration's decision to issue a second clinical hold on Regenxbio’s

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