May 2nd 2024
The April 2024 cardiology month in review spotlights FDA news and top updates from the American College of Cardiology 2024 Scientific Session.
FDA Priority Review Granted to Omalizumab for Adults, Children with Food Allergy
The decision by the FDA is a step closer to omalizumab’s potential approval, making it the potential first medicine to reduce reactions to many different food allergens after accidental exposure.
FDA Approves Iptacopan (Fabhalta) for Paroxysmal Nocturnal Hemoglobinuria
December 6th 2023The approval was based on data from the APPLY-PNH trial and APPOINT-PNH study, which showed iptacopan was superior for hemoglobin improvement in the absence of red blood cell transfusions and in transfusion avoidance rate compared to patients who stayed on anti-C5 treatments.
FDA Accepts Xanomeline-Trospium Drug Application for Schizophrenia Treatment
November 29th 2023The FDA will decide on the approval of xanomeline-trospium, a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, for the treatment of schizophrenia patients by September 2024.
FDA Approves Defencath to Reduce Catheter Bloodstream Infections in Adults Receiving Hemodialysis
November 15th 2023On November 15, 2023, the FDA approved Defencath. The new drug can reduce catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter.