US FDA staff questions confirmatory trial data for Intercept's liver disease drug Written By MD Bureau Team13 Sept 2024 3:14 PM ISTLondon: Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the effectiveness of Intercept's...
Yogurt consumption can reduce type 2 diabetes risk: US FDA allows qualified health claim Written By Medha Baranwal5 March 2024 6:59 PM ISTUSA: The U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it will not object to using certain qualified...
FDA approves first tricuspid valve replacement system for tricuspid regurgitation Written By Dr. Kamal Kant Kohli3 Feb 2024 11:15 AM ISTThe US Food and Drug Administration has approved Evoque as first transcatheter treatment for tricuspid regurgitation. The new transcatheter treatment...
FDA approves new oral therapy for treatment of Type 2 Diabetes in children Written By Dr. Kamal Kant Kohli22 Jun 2023 9:45 AM ISTUSA: The US Food and Drug Administration (FDA) has approved empagliflozin (Jardiance, Boehringer Ingelheim) and empagliflozin combined with metformin...
Postapproval study results of Impella show no mortality concerns: FDA Written By Medha Baranwal13 Dec 2022 8:00 PM ISTUSA: In its recently released update, the U.S. Food and Drug Administration (FDA) has said that final postapproval study (PAS) results for the Impella...
FDA clears SKOUT, an AI-assisted device for colorectal polyp detection Written By Dr. Kamal Kant Kohli29 Sept 2022 8:15 PM ISTUSA: A device called SKOUT has received FDA's 510(k) clearance for adults undergoing colorectal cancer screening or surveillance. SKOUT is a...
FDA approves Omidenepag isopropyl eye drops for reduction of elevated IOP Written By Dr. Kamal Kant Kohli27 Sept 2022 7:30 PM ISTUSA: Glaucoma causes damage to the optic nerve resulting in visual field loss, and remains a leading cause of irreversible blindness worldwide. Since...
FDA approves mavacamten for managing symptomatic obstructive hypertrophic cardiomyopathy Written By Dr. Kamal Kant Kohli2 May 2022 10:30 AM ISTThe US Food and Drug Administration has approved mavacamten (Camzyos) for treatment of symptomatic obstructive hypertrophic cardiomyopathy...
Popolymer matrix-based sublingual epinephrine continues to show promise: EPIPHAST study Written By Dr. Kamal Kant Kohli30 April 2022 9:00 AM ISTEpinephrine can reach therapeutic plasma concentrations via sublingual administration confirm researchers during the second part of the ongoing...
4th mRNA vaccine against COVID 19 approved for kidney transplant patients Dr. Nandita Mohan15 Jan 2022 4:25 PM ISTCovid 19 is known to cause multiorgan failure in most of its patients, Kidney trasplants have also increased their commplications are directly...
FDA approves first treatment for kids born without thymus Written By Dr Kartikeya Kohli9 Oct 2021 7:25 AM ISTThe U.S. Food and Drug Administration has approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder....
FDA permits marketing of Device to improve sleep disturbance due to PTSD Written By Dr. Kamal Kant Kohli7 Nov 2020 6:55 AM ISTThe U.S. Food and Drug Administration has allowed marketing of a new device that temporarily reduces sleep disturbance related to nightmares in adults...
