This episode examines the FDA’s clearance of GH Research’s clinical hold for GH001, a mebufotenin inhalation therapy that demonstrated fifteen point five MADRS reduction and seventy-three percent six-month remission in Phase 2b treatment-resistant depression trials. The briefing covers December twenty twenty-five neurology regulatory actions including Tris Pharma’s oxybate NDA acceptance, Prilenia’s five-hundred-patient ALS trial clearance, and inebilizumab approval for myasthenia gravis, alongside Sanofi’s tolebrutinib Phase 3 miss in primary progressive MS and Johnson & Johnson’s expanded embolic indication. Spine device clearances from BrainLab, Augmedics, Proprio, and others map sector convergence on additive manufacturing and augmented reality navigation platforms. The episode concludes with Medicus Pharma’s completion of enrollment in a ninety-patient Phase 2 trial of a doxorubicin-containing dissolvable microneedle array for basal cell carcinoma, with topline results expected in Q1 twenty twenty-six and multi-jurisdictional expansion underway.
