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FDA update

https://gastroenterology.acponline.org/archives/2019/08/23/6.htm. Based on data from an ongoing safety trial, the FDA has approved a new warning about an increased risk of blood ... The FDA has approved new warnings for the 10-mg twice-daily dose of
August 2019

FDA update

Liva Global Inc. recalled two lots of liquid probiotics due to the possibility of contamination by Pseudomonas aeruginosa, the FDA announced on Dec.
December 2021

FDA update

The FDA announced on May 26 that it is restricting the use of obeticholic acid (Ocaliva) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis. ... Based on the original clinical trials, the FDA believes the benefits of the drug
June 2021

FDA update

The FDA has approved nivolumab (Opdivo) 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, ... The drug is
April 2021

FDA update

Eleven lots of ranitidine tablets, USP (150 mg) were recalled by American Health Packaging due to the potential to contain excess amounts of N-nitrosodimethylamine (NDMA), a probable carcinogen, the FDA
March 2020

FDA update

The FDA authorized marketing of the first fully disposable duodenoscope on Dec. ... each year, and the FDA has encouraged innovative ways to improve their safety and effectiveness, particularly with regard to cleaning and disinfecting, the agency said in
December 2019

FDA update

One lot of pantoprazole sodium for injection (40 mg per vial) was recalled from hospitals nationwide, the FDA announced on Dec.
January 2018

FDA update

15 safety communication. To date, the FDA has cleared a fully disposable duodenoscope and two duodenoscopes with disposable endcaps. ... Please note, we recognize that a full transition away from conventional duodenoscopes to the newer, innovative models
January 2020

FDA update

On June 5, the FDA approved the first generic form of mesalamine delayed-release oral tablets USP (1.2 g).
June 2017

FDA update

https://gastroenterology.acponline.org/archives/2019/09/27/8.htm. To help address abuse and misuse, the FDA approved changes to the packaging for tablet and capsule forms of the ... The FDA has approved changes to the packaging for tablet and capsule
September 2019

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