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Mar 21, 2026
The FDA has issued draft guidance creating a "Plausible Mechanism Framework" to accelerate approval of individualized therapies for ultra-rare diseases where traditional clinical trials are not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.
Mar 04, 2026
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.
Feb 27, 2026
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.
