Surfactant replacement therapy (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants
Approvable designations
Priority review
Fast-track designations
Nonapprovable designations
Recommendations against approval
Get the latest industry news, event updates, and more from Managed healthcare Executive.
FDA Expands Kerendia’s Use to Treat Common Form of Heart Failure
July 14th 2025Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.
Read More