To foster safer use of over-the-counter loperamide (Imodium), the FDA is implementing restrictions on its packaging. ... The FDA will continue to evaluate the drug's safety.
The FDA has permitted marketing of the Hemospray device to treat most types of upper or lower GI bleeding, the agency announced on May 7.
The FDA on Jan. 26 approved the first radioactive drug to treat a rare group of cancers called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The FDA has expanded the approval of tofacitinib (Xeljanz) to treat adults with moderately to severely active ulcerative colitis, the agency announced on May 30.
Clinicians should determine baseline liver function before starting patients on obeticholic acid, the FDA said. ... Prior to starting patients on the drug, clinicians should determine baseline liver function, the FDA stated.
First drug approved to treat thrombocytopenia in adults with chronic liver disease who are having a medical procedure
The FDA recently approved avatrombopag (Doptelet) tablets to treat adults with chronic liver disease who have thrombocytopenia and are scheduled to have a medical or dental procedure, the agency announced on ... The medication is the first to be approved
manuals. The FDA on July 21 cleared the updated design and labeling for ED-530XT duodenoscopes by Fujifilm, but the manufacturer on the same day informed customers that it was recalling ... After receiving the new operation manuals, customers who
The manufacturers have not fulfilled requirements to conduct studies assessing the real-world effectiveness of device reprocessing, the FDA said. ... If they fail to properly respond to the warning letter, the FDA may take additional punitive action.
The FDA's recommendation follows a study finding that sodium polystyrene sulfonate also binds to many common oral medications, which decreases their absorption and effectiveness. ... The agency will update the drug's labels to include information about
The FDA approved plecanatide (Trulance) to treat adult patients with chronic idiopathic constipation, the agency announced in a Jan. ... Safety and efficacy were demonstrated in two 12-week, placebo-controlled trials of 1, 775 participants diagnosed with