News
When Your Drug Supplier Gets a Warning Letter: What Genzyme Ireland Means for Trial Supply Planning
14+ hour, 9+ min ago (797+ words) The Clinical Trial Vanguard When Your Drug Supplier Gets a Warning Letter: What Genzyme Ireland Means for Trial Supply Planning Picture the scenario: your clinical operations lead pulls up the FDA enforcement database on a Tuesday morning, runs the routine…...
Abbisko, Astra Zeneca Begin Phase I/II Trial of Lumipodlin With Osimertinib in EGFR-Mutant NSCLC
14+ hour, 12+ min ago (466+ words) The Clinical Trial Vanguard Abbisko, Astra Zeneca Begin Phase I/II Trial of Lumipodlin With Osimertinib in EGFR-Mutant NSCLC Among patients with EGFR-mutant advanced NSCLC, those who also carry high PD-L1 expression represent a stubborn clinical problem: they respond worse…...
The Pediatric CNS Immunotherapy Signal That Sponsors Are Underreading
14+ hour, 12+ min ago (681+ words) The Clinical Trial Vanguard The Pediatric CNS Immunotherapy Signal That Sponsors Are Underreading Three converging signals in pediatric CNS immunotherapy " a Phase 1 trial published in Nature Medicine, a 2017 FDA precedent that still shapes the field, and an FDA draft guidance…...
Trans Con CNP Shows Sustained Lower Limb Alignment Improvement in Achondroplasia at Week 104
1+ day, 14+ hour ago (375+ words) The Clinical Trial Vanguard Trans Con CNP Shows Sustained Lower Limb Alignment Improvement in Achondroplasia at Week 104 Leg bowing in children with achondroplasia is not a cosmetic concern. Severe genu varum drives chronic pain, restricts mobility, and frequently ends in…...
Mesoblast Seeks FDA Approval for Rexlemestrocel-L in LVAD Patients
1+ day, 14+ hour ago (448+ words) The Clinical Trial Vanguard Mesoblast Seeks FDA Approval for Rexlemestrocel-L in LVAD Patients Among the roughly 2, 500 patients who receive a left ventricular assist device in the United States each year as destination therapy, approximately 80 percent will live with that device…...
The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint
1+ day, 14+ hour ago (745+ words) The Clinical Trial Vanguard The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint Buried inside the June 25, 2026 issue of the New England Journal of Medicine is a result that the clinical trial design community should…...
When Your Sponsor Gets Acquired Mid-Trial: The Operational Playbook Sites Need Now
1+ day, 14+ hour ago (935+ words) The Clinical Trial Vanguard When Your Sponsor Gets Acquired Mid-Trial: The Operational Playbook Sites Need Now The coordinator email arrives on a Tuesday, usually mid-morning. The subject line says something like "Important Update Regarding Study Operations." The body explains that…...
Tonix Launches Phase 2 HORIZON Trial of TNX-102 SL for Major Depressive Disorder
1+ day, 14+ hour ago (466+ words) The Clinical Trial Vanguard Tonix Launches Phase 2 HORIZON Trial of TNX-102 SL for Major Depressive Disorder Antidepressants have historically targeted monoamine reuptake, yet roughly a third of patients with major depressive disorder fail to respond adequately to first-line treatment, and…...
Definium's Phase 3 LSD Win Is Real. The Fracture It Exposed Is Bigger.
2+ day, 8+ hour ago (611+ words) The Clinical Trial Vanguard Definium's Phase 3 LSD Win Is Real. The Fracture It Exposed Is Bigger. Rachel Yehuda, Director of the Parsons Research Center for Psychedelic Healing at Icahn School of Medicine at Mount Sinai, put it plainly in a…...
FDA Approves Roflumilast Cream for Plaque Psoriasis in Children Age 2+
2+ day, 14+ hour ago (469+ words) The Clinical Trial Vanguard FDA Approves Roflumilast Cream for Plaque Psoriasis in Children Age 2+ Pediatric psoriasis in children under 6 has long forced clinicians into an uncomfortable compromise: topical steroids that work but carry well-documented risks on thin or intertriginous skin,…...