FDA Approves Kerendia for Broader Heart Failure Population
On July 14, 2025, the US Food and Drug Administration (FDA) approved Bayer Pharmaceuticals’ Kerendia® (finerenone) for a new indication for the treatment of heart failure (HF) in adults who have left ventricular ejection fraction (LVEF) of 40% or more, including mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF). Initially approved in 2021 for chronic kidney disease (CKD) associated with type 2 diabetes, this expanded approval allows Kerendia to treat a broader HF population without CKD. The nonsteroidal mineralocorticoid receptor antagonist (nsMRA) demonstrated a 16% relative risk reduction in cardiovascular death or HF events in patients receiving standard-of-care therapy. The trial showed consistent benefits across subgroups, including those taking sodium-glucose cotransporter-2 (SGLT2) inhibitors. Originally approved in 10mg and 20mg doses for treating CKD associated with type 2 diabetes, Kerendia now has a 40mg tablet as well due to the significantly reduced cardiovascular death and heart failure events at higher doses. As a result, the 40mg tablet is now the recommended maintenance dose for select patients who have HF. Here is the updated prescribing information.
Prefilled Syringe of GSK’s Shingrix Vaccine Approved
The FDA approved GSK’sShingrix® (zoster vaccine recombinant, adjuvanted) in a prefilled syringe presentation for the prevention of shingles (herpes zoster) in adults aged 50 years and older, and those over 18 years of age who are at increased risk due to immunodeficiency or immunosuppression on July 17, 2025. This new formulation eliminates the need to reconstitute two separate vials, streamlining administration for healthcare professionals. Approval was based on data demonstrating technical comparability to the existing two-vial formulation. The recommended dosing remains two intramuscular (IM) injections six months apart, consistent with Centers for Disease Control and Prevention (CDC) guidelines. Safety information includes the potential for local and systemic reactions, and rare post-marketing reports of Guillain-Barré syndrome. The updated prescribing information is available here.
FDA Approvals: Maintaining Drug Approval Momentum Issues Document This document provides a mid-year summary of FDA drug approvals in 2025, highlighting the agency’s resilience in maintaining approval momentum despite staffing cuts and leadership changes. It details the number and types of approvals, notes missed target action dates and outlines future initiatives involving AI to streamline drug review processes.