The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
The FDA has accepted New Drug Applications for rusfertide in polycythemia vera with Priority Review and tirabrutinib for relapsed/refractory primary CNS lymphoma under Accelerated Approval, with PDUFA dates set for Q3 2026 and December 2026 respectively.
Palvella Therapeutics announced positive topline results from its Phase 3 SELVA study of QTORIN 3.9% rapamycin for microcystic lymphatic malformations, meeting all primary and secondary endpoints with strong tolerability. The company plans an NDA submission in H2 2026.
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07478133 |
Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans |
COMPLETED | NA |
| NCT07450716 |
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NOT_YET_RECRUITING | EARLY_PHASE1 |
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NOT_YET_RECRUITING | PHASE4 |
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RECRUITING | NA |
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NOT_YET_RECRUITING | PHASE1 |
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A Clinical Study to Assess the Safety and Effectiveness of Utixira Lotion and Utixira Tablet in Healthy Adult Human Subjects With Dry or Sensitive Skin Prone to Mild to Moderate Pruritus and Urticaria |
NOT_YET_RECRUITING | NA |
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Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus |
COMPLETED | NA |
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RECRUITING | NA |
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Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch |
RECRUITING | NA |
| NCT06737484 |
Effect of Topically Applied Olive Oil on Pruritus in Hemodialysis Patients: Pretest-posttest Model With Control Group |
COMPLETED | NA |
