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FDA News
Onyx Frontier Drug-Eluting Stent Receives FDA Approval for CAD
May 13, 2022
Announced on May 13, the Onyx Frontier DES carries the same clinical indications as Medtronic's Resolute Onyx DES and will be available in 2.0 mm sizes as well as 4.50-5.00 mm sizes that can be expanded to 6.00 mm.
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 Approves Mavacamten (Camzyos) for Obstructive Hypertrophic Cardiomyopathy
April 29, 2022
Bristol Myers Squibb announced the FDA's approval of mavacamten for symptomatic obstructive hypertrophic cardiomyopathy in a press release on April 28.
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 Approves S.M.A.R.T. RADIANZ Vascular Stent System for Radial Peripheral Procedures
March 11, 2022
With the FDA approval announced by Cordis on March 10, the company is hopeful the S.M.A.R.T. RADIANZ Vascular Stent System can help optimize radial access and improve patient outcomes.
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.
Cardiology's Top FDA Approvals in 2021
December 27, 2021
To celebrate the end of 2021, Practical Cardiology has created a list of the top FDA approvals from the past year based on popularity and relevance to current standards of care.