First AI-powered non-invasive device for skin cancer detection receives FDA clearance Medha Baranwal3 Feb 2024 10:15 AM ISTUSA: The US FDA (Food and Drug Administration) has announced clearance of an artificial intelligence (AI)-powered device designed for non-invasive...
Second PFA system for paroxysmal atrial fibrillation receives FDA approval Dr. Kamal Kant Kohli2 Feb 2024 11:00 AM ISTUSA: The US Food and Drug Administration (FDA) has approved Farapulse pulsed field ablation (PFA) system for paroxysmal atrial fibrillation. The new...
Garadacimab, XIIa inhibitor, receives FDA and EMA Filing acceptance for hereditary angioedema Medha Baranwal22 Dec 2023 5:45 PM ISTUSA: Garadacimab, a first-in-class factor XIIa inhibitor, has received the Food and Drug Administration (FDA) and European Medicines Agency (EMA)...
FDA approved Bimzelx for plaque psoriasis now commercially available Dr. Kamal Kant Kohli15 Nov 2023 7:15 PM ISTIn October US Food and Drug Administration had approved for plaque psoriasis. Bimzelx, an IL-17A and IL-17F inhibitor is now commercially available...
First: FDA approves low dose Colchicine for reduction of CV events in high risk patients Medha Baranwal22 Jun 2023 11:00 AM ISTUSA: Colchicine 0.5 mg (Lodoco) has received US FDA (Food and Drug Administration) approval as the first anti-inflammatory indicated for reducing...
FDA approves mavacamten for hypertrophic cardiomyopathy Jacinthlyn Sylvia19 Jun 2023 9:30 AM ISTBristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to...
Ferric carboxymaltose injection receives FDA approval for iron deficiency anaemia in heart failure Medha Baranwal7 Jun 2023 11:00 AM ISTUSA: The US Food and Drug Administration (FDA) has expanded the indication for ferric carboxymaltose injection (Injectafer) for treating iron...
World's most expensive drug: USFDA nod to HEMGENIX worth USD 3.5 million a dose Roshni Dhar25 Nov 2022 5:41 PM ISTGlobal biotechnology leader CSL has announced that the U.S. Food and Drug Administration (USFDA) has approved HEMGENIX (etranacogene...
Tzield, first drug to delay type 1 diabetes onset, receives FDA approval Medha Baranwal19 Nov 2022 11:15 AM ISTTZIELD is the first disease-modifying therapy for type 1 diabetes, a life-threatening autoimmune disease.USA: Tzield (teplizumab-mzwv), an injection...
USFDA Commissioner Dr Robert M Califf tests COVID positive Ruchika Sharma8 Nov 2022 3:30 PM ISTUS: The U.S. Food and Drug Administration said on Monday that Commissioner Dr. Robert M. Califf tested positive for COVID-19 over the weekend while...
Aurobindo Pharma subsidiary's plant gets one observation from USFDA Kajal Rajput30 Aug 2022 12:23 PM ISTHyderabad: Aurobindo Pharma on Monday said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit. The...
Possible carcinogens found in Merck's Sitagliptin drugs Januvia, Janumet: USFDA Ruchika Sharma10 Aug 2022 5:08 PM ISTNew Delhi: The U.S. Food and Drug Administration said on Tuesday certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and...
