FDA News

Vedolizumab (Entyvio) SC Approved for Maintenance Therapy in Adults with Moderately to Severely Active Crohn Disease
April 22, 2024

Vedolizumab for subcutaneous injection in now indicated for maintenance therapy following IV induction in both Crohn disease and ulcerative colitis.

FDA Approves Benralizumab as Add-On Maintenance Therapy for Children with Severe Asthma: Daily Dose
April 19, 2024

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

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.