FDA News

 

Understanding the Mavacamten Approval: Perspective from an oHCM Specialist

April 29, 2022

Martin Maron, MD, medical director of the Hypertrophic Cardiomyopathy Center at Lahey Hospital and Medical Center, participates in a Q&A related to the approval of mavacamten for symptomatic obstructive hypertrophic cardiomyopathy.

FDA Issues CRL for Vadadustat in Treatment of Anemia Due to CKD

March 30, 2022

On March 30, Akieba Therapeutics announced the receipt of a CRL from the FDA for their NDA for vadadustat as a treatment for anemia due to chronic kidney dialysis in adult patients on dialysis and not on dialysis.

Cardiology Month in Review: March 2022

March 26, 2022

Each month, our editorial staff compiles a month in review highlighting the most popular content from the past month. March's month in review features news on EMPA-KIDNEY, VITAL-AF, COSMOS, and more.

FDA Issues CRL for Bardoxolone Methyl in CKD Caused By Alport Syndrome

February 28, 2022

The CRL for bardoxolone methyl for treatment of CKD caused by Alport syndrome comes less than 3 months after an FDA advisory committee voted unanimously against approval of Reata Pharmaceutical's once-daily, orally administered activator of Nrf2.

FDA Approves Empagliflozin for Treatment in Adults with Heart Failure

February 24, 2022

Announced on Feb. 24, the approval indicates the SGLT2 inhibitor for reducing risk of CV death and hospitalizations for heart failure in adults with heart failure and is supported by data from the EMPEROR-Preserved trial.

FDA Expands Indication for CardioMEMS HF System, Includes NYHA Class II, Worsening HF Patients

February 21, 2022

Announced by Abbott on Feb. 21, the expanded indication for the CardioMEMS HF System now includes patients with NYHA Class II heart failure and those with worsening heart failure, which expands the potential patient population by 1.2 million additional patients.