Bavarian Nordic became the first company to win approval for the only vaccine designed to prevent smallpox and monkeypox disease in adults who are considered at high risk of the viruses.
Abbott’s ARCHITECT STAT High Sensitivity Troponin-I blood test received clearance from the U.S. Food and Drug Administration to help identify heart attacks several hours sooner than standard troponin tests and help improve diagnosis in women.
The U.S. Food and Drug Administration approved Novo Nordisk’s Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.
The FDA greenlit GlaxoSmithKline’s Nucala (mepolizumab) for treating severe eosinophilic asthma in children as young as 6 years.
Zelnorm was relaunched by Alfasigma USA for the treatment of irritable bowel syndrome with constipation (IBS-C).
The U.S. Food and Drug Administration approved South African drugmaker Aspen Pharmacare’s hydroxyprogesterone caproate (HPC), which is used to prevent preterm birth in pregnant women.
The U.S. Food and Drug Administration approved Xeris Pharmaceuticals Inc.’s glucagon pen Gvoke, which aims to treat severely low sugar levels in diabetes patients.
The U.S. Food and Drug Administration gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease.
The U.S. FDA approved Kyowa Kirin’s Nourianz (istradefylline) as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who experience “off” episodes.
The FDA approved Eli Lilly and Co.’s Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis, also known as radiographic axial spondyloarthritis.
