The FDA has issued draft guidance creating a "Plausible Mechanism Framework" to accelerate approval of individualized therapies for ultra-rare diseases where traditional clinical trials are not feasible. The guidance focuses on gene editing and RNA-based treatments targeting specific genetic abnormalities.
Citius Pharmaceuticals reported $3.9 million in first revenue from LYMPHIR's December 2025 launch for cutaneous T-cell lymphoma, while subsidiary Citius Oncology announced positive Phase 1 data showing 86% response rate when LYMPHIR was administered prior to CAR-T therapy in high-risk lymphoma patients.
The American Medical Association and University of Minnesota's Vaccine Integrity Project are creating an independent vaccine review system after major changes at the CDC raised concerns among public health experts.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07606573 |
The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation |
NOT_YET_RECRUITING | NA |
| NCT07605975 |
Measuring and Enhancing Creativity and Brain Flexibility in Adolescents With Depression |
COMPLETED | NA |
| NCT07602686 |
MRI and Local Anesthesia |
NOT_YET_RECRUITING | NA |
| NCT07601685 |
MERC Proteins in Saliva and GCF in Periodontal Disease (ELISA Study) |
COMPLETED | |
| NCT07592052 |
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption |
NOT_YET_RECRUITING | |
| NCT07583823 |
Elevated Rate Pacing of Cardiac Amyloidosis |
RECRUITING | NA |
| NCT07573306 |
Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients |
NOT_YET_RECRUITING | |
| NCT07568860 |
Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome |
NOT_YET_RECRUITING | NA |
| NCT07547696 |
CARRII Native Intervention Optimization Trial |
NOT_YET_RECRUITING | NA |
| NCT07546708 |
The Black Immigrant Project |
RECRUITING | NA |
