Search results for "FDA update"
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
Monkeypox may be transmitted through fecal microbiota transplantation
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
Endoscopic spray device approved to be marketed to treat GI bleeding
The device delivers a mineral blend to sites of upper or lower GI bleeding and is applied during an endoscopic procedure.
https://gastroenterology.acponline.org/archives/2018/05/25/7.htm
25 May 2018
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
New drug approved to treat digestive tract cancers
The orphan drug is indicated to treat adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
https://gastroenterology.acponline.org/archives/2018/02/23/10.htm
23 Feb 2018
IBS-D drug should not be prescribed to patients without gallbladders
The FDA suggests that clinicians should consider alternatives to eluxadoline in this population.
https://gastroenterology.acponline.org/archives/2017/03/24/8.htm
24 Mar 2017
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
More patient deaths associated with intragastric balloon weight-loss systems
Clinicians should closely monitor patients with intragastric balloons for complications and explain symptoms that could be signs of serious or life-threatening problems, the FDA advised.
https://gastroenterology.acponline.org/archives/2018/06/22/7.htm
22 Jun 2018
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
Drug cleared to treat moderately to severely active ulcerative colitis
It is the first oral medication to be approved for chronic use in this population.
https://gastroenterology.acponline.org/archives/2018/06/22/6.htm
22 Jun 2018