Search results for "FDA update"
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
Ulcerative colitis medicine may increase risk of serious heart-related problems, cancer
Preliminary results from a safety clinical trial indicate that tofacitinib may be associated with an increased risk of serious heart-related events and cancer compared to tumor necrosis factor inhibitors.
https://gastroenterology.acponline.org/archives/2021/02/26/8.htm
26 Feb 2021
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
Marketing authorized for first AI device to detect potential signs of colon cancer
The device uses artificial intelligence (AI) based on machine learning to assist clinicians in the real-time detection of lesions, such as polyps or suspected tumors, in the colon during a colonoscopy.
https://gastroenterology.acponline.org/archives/2021/04/23/10.htm
23 Apr 2021
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 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
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
Laxative recalled due to potential microbial contamination
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
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
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