Search results for "FDA Update"
Blood test for colorectal cancer screening approved
The test can be used to screen for colorectal cancer in average-risk individuals who are 45 years of age or older.
https://gastroenterology.acponline.org/archives/2024/08/23/8.htm
23 Aug 2024
New medication approved for primary biliary cholangitis
The FDA recently approved elafibranor oral tablets (Iqirvo) for primary biliary cholangitis.
https://gastroenterology.acponline.org/archives/2024/06/28/12.htm
28 Jun 2024
Monkeypox may be transmitted through fecal microbiota transplantation
Because of this risk, the FDA determined that additional protections are required for any investigational use of fecal microbiota transplantation if it involves stool donated on or after March 15, 2022.
https://gastroenterology.acponline.org/archives/2022/09/23/10.htm
23 Sep 2022
Another warning for endoscope manufacturer after facility inspection in Japan
The warning letter to Olympus Medical Systems Corporation followed previous warning letters issued to the firm and one of its subsidiaries and described numerous violations, including failure to evaluate and report user reports of adverse events.
https://gastroenterology.acponline.org/archives/2023/04/21/7.htm
21 Apr 2023
FDA approves first medication for adults with hepatorenal syndrome
The treatment is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
https://gastroenterology.acponline.org/archives/2022/09/23/11.htm
23 Sep 2022
Incontinence management system recalled due to potential interference with other devices
About a month after issuing an urgent medical device correction, the manufacturer announced a class I recall of the WatchCare Incontinence Management System due to potential radio frequency interference with other medical devices.
https://gastroenterology.acponline.org/archives/2022/12/23/8.htm
23 Dec 2022
FDA approves first fecal microbiota product
The product, which is prepared from donated, tested stool and administered rectally as a single dose, is indicated for the prevention of recurrent Clostridioides difficile infection in adults who have already completed antibiotic treatment for a recurrence.
https://gastroenterology.acponline.org/archives/2022/12/23/7.htm
23 Dec 2022
Urgent medical device correction for incontinence management system
There is a potential for radio frequency interference between the WatchCare Incontinence Management System and other medical devices in the vicinity, such as insulin pumps, telemetry devices, and infusion injection pumps.
https://gastroenterology.acponline.org/archives/2022/11/18/10.htm
18 Nov 2022
First oral treatment approved for moderate to severe Crohn's disease
Upadacitinib (Rinvoq) is now approved to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
https://gastroenterology.acponline.org/archives/2023/05/26/9.htm
26 May 2023
FDA restricts use of liver disease drug in certain patients
The agency added new warnings to the prescribing information for obeticholic acid, including a contraindication in patients with primary biliary cholangitis and advanced cirrhosis.
https://gastroenterology.acponline.org/archives/2021/06/25/7.htm
25 Jun 2021