Women Report Higher Rates of Statin-Associated Diabetes, FDA Data Reveals Medha Baranwal23 Dec 2024 9:00 AM ISTUSA: A recent analysis of post-marketing spontaneous adverse drug event (ADE) reports submitted to the US Food and Drug Administration (FDA)...
Pfizer RSV Vaccine Abrysvo gets USFDA ok for high-risk adults aged 18-59 MD Bureau23 Oct 2024 2:37 PM ISTThe approval for the vaccine, Abrysvo, in adults aged 18 to 59 was based on the results from a late stage trial in which two doses of the vaccine were...
Kezar to terminate mid-stage trial for Lupus treatment MD Bureau20 Oct 2024 9:30 AM ISTThe regulator's decision came after the company paused the study in September to review safety data following the deaths of four patients.
Pfizer Hemophilia drug Hympavzi Receives USFDA Approval MD Bureau14 Oct 2024 2:08 PM ISTPfizer announced on Friday that the U.S. Food and Drug Administration has granted approval for its once-weekly injection designed to treat the two...
Manufacturing Defects: Glenmark Subsidiary Recalls Products in US Meghna A Singhania14 Oct 2024 1:14 PM ISTNew York: Glenmark Pharmaceuticals is recalling two products in the U.S. due to manufacturing problems, as reported by the U.S. Food and Drug...
EU gives marketing authorization for Novavax updated 2024-2025 Nuvaxovid COVID vaccine Ruchika Sharma11 Oct 2024 10:00 AM ISTGaithersburg: Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, has announced that the European...
Compatible with Apple AirPods Pro headphones, First Over-the-Counter Hearing Aid Software gets USFDA nod MD Bureau Team13 Sept 2024 3:10 PM ISTThe U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be...
US FDA approves Emergent's smallpox vaccine for people at high risk of mpox MD Bureau Team1 Sept 2024 12:00 PM ISTLondon: The U.S. Food and Drug Administration (FDA) has approved expanded use of Emergent BioSolutions' ACAM2000 smallpox vaccine to include...
FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain MD Bureau Team1 Sept 2024 10:45 AM ISTBengaluru: The U.S. Food and Drug Administration on Friday granted emergency use authorization for an updated version of Novavax's COVID...
FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test Dr. Kamal Kant Kohli30 Jun 2024 8:00 PM ISTToday, the US Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first...
FDA approves once-daily oral antihypertensive Aprocitentan for uncontrolled BP Medha Baranwal21 March 2024 8:00 PM ISTUSA: The US Food and Drug Administration (FDA) has approved aprocitentan (Tryvio) for treating hypertension in combination with other antihypertensive...
AGENT drug-coated balloon receives FDA approval for treating in-stent restenosis Medha Baranwal4 March 2024 12:30 AM ISTUSA: The US Food and Drug Administration (FDA) has approved a paclitaxel-coated device, AGENT, for treating in-stent restenosis, making it the first...
