Search results for "FDA update"


 
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New data show even higher rates of duodenoscope contamination

The FDA is exploring additional steps to reduce contamination rates, which were higher in postmarket surveillance studies than the agency initially anticipated.
https://gastroenterology.acponline.org/archives/2019/04/26/9.htm
26 Apr 2019

Marketing authorized for endoscopic sleeve gastroplasty systems

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

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

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

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

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

First drug approved for fourth-line treatment of advanced GI stromal tumors

A new kinase inhibitor, ripretinib, is now indicated to treat adults with advanced GI stromal tumors who have previously received three or more kinase inhibitor therapies, including imatinib.
https://gastroenterology.acponline.org/archives/2020/05/22/9.htm
22 May 2020

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 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

Postapproval studies find risks of gastric balloon devices used for weight loss

A small number of patients experienced balloon hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloons.
https://gastroenterology.acponline.org/archives/2020/05/22/8.htm
22 May 2020

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