Lung fibrosis (pulmonary fibrosis) is a chronic lung disease characterized by progressive scarring and stiffening of lung tissue, which impairs breathing and oxygen transfer. The condition can worsen over time and may result from multiple causes or be idiopathic.
The FDA has accepted Savara’s BLA for MOLBREEVI in autoimmune PAP and granted Priority Review with an action date of August 22, 2026. The application includes data showing improved pulmonary gas transfer, quality of life, and clinical symptoms.
The FDA has expanded approval of GSK's Arexvy RSV vaccine to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease, based on phase 3b trial data showing noninferior immune response.
The FDA has filed Savara's biologics license application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a target action date of August 22, 2026.
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07236541 |
Impact of Airway Mucus Plugs on Secondary Pulmonary Fibrosis in COPD Patients: A Single-Center Case-Control Study |
RECRUITING | |
| NCT07088185 |
Pulmonary Outcomes on Patients With Lung Fibrosis |
ACTIVE_NOT_RECRUITING | NA |
| NCT06751069 |
Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease |
RECRUITING | NA |
| NCT06189820 |
Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases |
RECRUITING | PHASE2 |
| NCT05648734 |
Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis |
COMPLETED | |
| NCT05572346 |
Digital App for Telerehabilitation in Respiratory Diseases |
UNKNOWN | |
| NCT05516550 |
Study to Assess Efficacy and Safety of Treamid for Patients With Reduced Exercise Tolerance After COVID-19 |
UNKNOWN | PHASE2/PHASE3 |
| NCT05382572 |
Pulmonary Fibrosis Foundation Community Registry |
RECRUITING | |
| NCT05191381 |
Immune Modulation by Exosomes in COVID-19 |
RECRUITING | |
| NCT04990531 |
Low-field Magnetic Resonance Imaging of Pediatric COVID-19 |
UNKNOWN | NA |
