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
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
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
HCV drug approved as 8-week regimen
The combination drug is indicated to treat all treatment-naive adults and some children who have chronic hepatitis C virus (HCV) genotypes 1 through 6 infection, either without cirrhosis or with compensated cirrhosis.
https://gastroenterology.acponline.org/archives/2019/10/25/7.htm
25 Oct 2019
Ranitidine recalled due to nitrosamine impurity
American Health Packaging recalled 11 lots of the histamine-2 receptor antagonist due to the potential presence of excess amounts of N-nitrosodimethylamine, a probable carcinogen.
https://gastroenterology.acponline.org/archives/2020/03/27/10.htm
27 Mar 2020
Laxatives and antacids recalled due to microbial contamination
The recall includes several lots of milk of magnesia and magnesium hydroxide/aluminum hydroxide/simethicone sold to clinics and hospitals nationwide.
https://gastroenterology.acponline.org/archives/2022/06/24/9.htm
24 Jun 2022
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
New boxed warning for ulcerative colitis drug
Based on data from an ongoing safety trial, the FDA has approved a new warning about an increased risk of blood clots and of death with the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR).
https://gastroenterology.acponline.org/archives/2019/08/23/6.htm
23 Aug 2019
FDA clears first fully disposable duodenoscope
The device is intended to be used on a single patient, removing the infection risks associated with ineffective cleaning and disinfecting between patients.
https://gastroenterology.acponline.org/archives/2019/12/27/6.htm
27 Dec 2019