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
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
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
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
Proton-pump inhibitor recalled
One lot of pantoprazole sodium for injection (40 mg per vial) was recalled in December.
https://gastroenterology.acponline.org/archives/2018/01/26/6.htm
26 Jan 2018
Updated design, labeling cleared for duodenoscope
The changes aim to reduce the potential for patient fluids to leak into the closed elevator channel and underneath the distal cap.
https://gastroenterology.acponline.org/archives/2018/02/23/8.htm
23 Feb 2018
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
Data show higher-than-expected rates of duodenoscope contamination
While the number of medical device reports associated with patient infections has declined by 62% since peaking in 2015, the FDA and duodenoscope manufacturers continue to address issues around device reprocessing.
https://gastroenterology.acponline.org/archives/2018/12/28/7.htm
28 Dec 2018
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 new drug for travelers' diarrhea
Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults with travelers' diarrhea in Guatemala and Mexico.
https://gastroenterology.acponline.org/archives/2018/11/27/6.htm
27 Nov 2018