Search results for "FDA update"


 
Results 1 - 10 of about 71 for "FDA update".
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Generic form of mesalamine approved

The drug is indicated to induce remission in adults with active, mild to moderate ulcerative colitis and to maintain remission of ulcerative colitis.
https://gastroenterology.acponline.org/archives/2017/06/23/6.htm
23 Jun 2017

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

Warning on risks of serious adverse events with use of fecal microbiota for transplantation

Several patients who have received fecal microbiota for transplantation from a U.S.-based stool bank have developed serious or life-threatening infections caused by pathogenic bacteria.
https://gastroenterology.acponline.org/archives/2020/03/27/9.htm
27 Mar 2020

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

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

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

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

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

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

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

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