FDA News

How the CLEAR Outcomes Trial Made CV Risk Reduction History, with Lead Investigator Steven Nissen, MD
April 18, 2024

Bempedoic acid became the first nonstatin LDL-C lowering medication indicated to reduce CV risk in both primary and secondary prevention. Nissen explains how.

FDA Approves Benralizumab as Add-On Maintenance Therapy for Children Aged 6-11 Years with Severe Asthma
April 11, 2024

The additional indication for benralizumab was supported by data from the phase 3 TATE trial.

FDA Clears First AI-Based Algorithm to Detect Heart Failure during Routine Exams
April 03, 2024

The Low EF AI is designed to detect low ejection fraction in 15 seconds during a primary care exam.

FDA Approves Fixed-Dose Macitentan/Tadalafil Tablets for PAH: Daily Dose
April 03, 2024

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

FDA Approves Aprocitentan for Treatment-Resistant HTN: Daily Dose
March 29, 2024

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

FDA Issues Warning Letters to 6 Companies Marketing Misbranded OTC Topical Analgesics
March 29, 2024

Specifically, the topical analgesics, available over the counter, may contain higher than labeled concentrations of lidocaine, according to the agency.

FDA Approves Vadadustat for Treatment of Anemia due to CKD in Patients on Dialysis
March 28, 2024

The FDA approved the oral medication to treat anemia in adult patients with chronic kidney disease on dialysis for at least 3 months.

FDA Approves Fixed-Dose Macitentan/Tadalafil Tablets (Opsynvi) For Pulmonary Arterial Hypertension
March 25, 2024

For the first time, 2 drugs recommended as first line treatment for PAH are combined in a single oral once-daily therapy, which could reduced burden of care.

FDA Expands Bempedoic Acid Label to Include Primary, Secondary CV Risk Reduction, With or Without Statins
March 24, 2024

Bempedoic acid is now the only non-statin therapy indicated for primary CVD prevention, with potential to expand treatment access to millions, said Esperion Therapeutics.

Michael A. Weber, MD, on aprocitentan approval: A new approach to managing hypertension
March 21, 2024

Michael A. Weber, MD, an investigator in the PRECISION study, discusses the newly FDA approved drug aprocitentan (Tryvio), and its promise for helping patients with treatment-resistant hypertension.