FDA approved zenocutuzumab-zbco (Bizengri) for NRG1 fusion-positive cholangiocarcinoma on May 8, 2026. The eNRGy trial showed a 36.8% ORR. It also received priority review, breakthrough, and orphan designations.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
The FDA approved Zycubo (copper histidinate) on January 13, 2026, as the first treatment for Menkes disease in pediatric patients, following resolution of manufacturing compliance concerns that led to an initial rejection in September 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07752706 |
Breathing Exercises for Dyspnea and Anxiety in Heart Failure |
ACTIVE_NOT_RECRUITING | NA |
| NCT07746596 |
Su Jok for Dyspnea and Fatigue |
COMPLETED | NA |
| NCT07746570 |
SU JOK THERAPY TO IMPROVE DYSPNEA AND INSOMNIA IN ASTHMA |
COMPLETED | NA |
| NCT07728773 |
A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot) |
NOT_YET_RECRUITING | NA |
| NCT07727824 |
Endoscopic Treatment |
NOT_YET_RECRUITING | NA |
| NCT07727590 |
ER-VISION-AI Study |
NOT_YET_RECRUITING | NA |
| NCT07726628 |
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea |
NOT_YET_RECRUITING | NA |
| NCT07685106 |
Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea. |
RECRUITING | |
| NCT07653204 |
Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain |
NOT_YET_RECRUITING | |
| NCT07641413 |
Lung and Heart Function Across Decades of Life in Health |
RECRUITING |
