Search results for "FDA update"
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
More laxatives recalled due to microbial contamination
Recalled products were distributed nationwide at CVS drugstore locations.
https://gastroenterology.acponline.org/archives/2022/07/22/10.htm
22 Jul 2022
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
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
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
First immunotherapy approved for initial treatment of gastric cancer
Nivolumab (Opdivo) is approved in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.
https://gastroenterology.acponline.org/archives/2021/04/23/9.htm
23 Apr 2021
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
Hepatic artery infusion pumps recalled
The recall was initiated after reports from clinicians that the pumps were delivering medications faster than expected.
https://gastroenterology.acponline.org/archives/2022/09/23/12.htm
23 Sep 2022
Marketing authorized for new device that removes dead pancreatic tissue
The system is the first device indicated to treat patients with walled-off pancreatic necrosis resulting from complications of acute pancreatitis.
https://gastroenterology.acponline.org/archives/2021/01/22/7.htm
22 Jan 2021
FDA recommends transition to duodenoscopes with disposable endcaps
While a full transition away from conventional duodenoscopes to innovative models will take time, health care facilities should develop plans to transition away from older models that have fixed endcaps, the FDA said.
https://gastroenterology.acponline.org/archives/2019/09/27/7.htm
27 Sep 2019