Search results for "FDA Update"


 
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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

First oral treatment approved for moderate to severe Crohn's disease Monthly

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

Another warning for endoscope manufacturer after facility inspection in Japan Gastroenterology Monthly

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

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 Monthly

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

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

FDA approves first medication for adults with hepatorenal syndrome Monthly

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

Monkeypox may be transmitted through fecal microbiota transplantation Monthly

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

Marketing authorized for endoscopic sleeve gastroplasty systems Monthly

The systems are the first to be authorized by the FDA for the minimally invasive weight-loss procedure, which is intended for adults with obesity who have not been able to lose weight or maintain weight loss through measures such as diet and exercise.
https://gastroenterology.acponline.org/archives/2022/08/26/12.htm
26 Aug 2022

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

Laxatives and antacids recalled due to microbial contamination Monthly

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 approves first treatment for eosinophilic esophagitis

The monoclonal antibody is indicated to treat the chronic immune disorder in adults and pediatric patients ages 12 years and older who weigh at least 40 kg.
https://gastroenterology.acponline.org/archives/2022/05/27/9.htm
27 May 2022

Use duodenoscopes that are fully disposable or have disposable components, FDA recommends

Interim results from one duodenoscope model with a removable component showed a contamination rate of 0.5%, compared with as high as 6% among older duodenoscope models, an FDA safety communication noted.
https://gastroenterology.acponline.org/archives/2022/04/22/11.htm
22 Apr 2022

Laxative recalled due to potential microbial contamination Monthly

A company recently recalled one lot of senna syrup, which was distributed to a wholesaler, due to potential microbial contamination.
https://gastroenterology.acponline.org/archives/2022/01/28/6.htm
28 Jan 2022

Probiotics recalled due to bacterial contamination

A company recently recalled two lots of liquid probiotics due to the possibility of contamination with Pseudomonas aeruginosa.
https://gastroenterology.acponline.org/archives/2021/12/17/9.htm
17 Dec 2021

FDA requires updated boxed warnings on heart-related events, other risks for certain Janus kinase inhibitors

The agency is requiring revisions to the boxed warning for the arthritis and ulcerative colitis medicine tofacitinib, as well as two other Janus kinase inhibitors, to include information about the risks of serious heart-related events, cancer, blood clots, and death.
https://gastroenterology.acponline.org/archives/2021/09/24/9.htm
24 Sep 2021

FDA restricts use of liver disease drug in certain patients Monthly

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

First immunotherapy approved for initial treatment of gastric cancer Monthly

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

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