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Category Lists Established Under Windsor Framework Set to Impact Pharma Sector by 2025

March 8, 2026
A comprehensive list of individual human medicinal products will be implemented on January 1, 2025, as part of the new arrangements established by the Windsor Framework. This framework aims to streamline regulatory processes and enhance the movement of goods between the UK and the EU, particularly in the pharmaceutical sector. The introduction of these category…

Bioxytran Reports Positive Study Results for a Broad-Range Antiviral Drug in Mild-to-Moderate COVID-19

March 8, 2026
Bioxytran, Inc. recently announced promising results from a randomized, double-blind, placebo-controlled Phase 1b/2a clinical study of oral ProLectin-M in hospitalized patients with mild to moderate COVID-19. The study demonstrated that the highest evaluated dose of ProLectin-M (16,800 mg/day) led to statistically significant earlier viral clearance and faster clinical improvement by Day 5 compared to placebo,…

UniQure’s Huntington’s Disease Therapy Approval Blocked by FDA Amid Regulatory Concerns

March 7, 2026
UniQure announced on Monday that its efforts to secure approval for a Huntington’s disease treatment from the Food and Drug Administration (FDA) remain obstructed, marking another hurdle for a therapy that previously seemed poised for approval. In a recent meeting with the FDA, UniQure learned that regulators remain unconvinced that the data from its completed…

UniQure Faces Setback as FDA Prefers Randomized Trial for Huntington’s Treatment

March 7, 2026
UniQure’s stock experienced a decline on Monday following unfavorable feedback from the FDA regarding its Huntington’s disease program, AMT-130. The agency indicated that the current application lacks sufficient data to support its approval, specifically expressing a preference for a randomized clinical trial to validate the treatment’s efficacy. This development underscores the FDA’s stringent requirements for…

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