FDA News

FDA Approves Finerenone for Heart Failure With LVEF ≥40% Following Positive Phase 3 Data
July 14, 2025

FDA approval based on FINEARTS-HF trial showing 16% risk reduction in CV death and HF events.

FDA Grants Full Approval of Moderna’s COVID-19 Vaccine for High-Risk Children Aged 6 Months to 11 Years
July 10, 2025

Moderna’s Spikevax receives full FDA approval for use in children at increased risk for COVID-19, expanding protection ahead of the 2025–2026 virus season.

Donanemab Label Revised: New Dosing Schedule Approved for Early Alzheimer’s Treatment
July 09, 2025

The FDA approved updated dosing for donanemab in early Alzheimer disease, reducing ARIA-E risk by 41% without compromising efficacy.

FDA Approves Dupilumab for Treatment of Bullous Pemphigoid in Adults
June 20, 2025

Dupilumab is the first targeted treatment for BP to receive FDA approval, showing improved remission rates, itch reduction, and lower steroid use in pivotal trial.

FDA Clears Happy Ring for At-Home Diagnosis of Sleep Apnea and Insomnia
June 19, 2025

The FDA cleared Happy Ring, a wearable device for at-home diagnosis of sleep disorders, enhancing access to vital sleep health solutions.

FDA Accepts NDA for Anaphylm™, a Sublingual Epinephrine Film for Treatment of Severe Allergic Reactions
June 17, 2025

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026.

George Medicines Announces FDA Approval of Polypill for Treatment of Hypertension in Adults
June 10, 2025

The novel triple fixed-dose combination of telmisartan, amlodipine and indapamide, is the first of its kind approved for initial treatment of hypertension.

Clesrovimab Wins FDA Approval for Prevention of RSV LRTD in Infants During First RSV Season
June 10, 2025

The preventive monoclonal antibody is designed to protect infants against RSV infection through 5 months and is administered at the same dose, regardless of weight.

FDA Clears First Blood Test for Alzheimer Disease: Daily Dose
June 02, 2025

Your daily dose of the clinical news you may have missed.

FDA Advisory Panel Recommends Continued Use of Monovalent JN.1 Strain for COVID-19 Vaccines
May 27, 2025

FDA panel endorses continued use of monovalent JN.1 strain for COVID-19 vaccines, aligning with global health recommendations amid evolving variants.