Five additional deaths have occurred in patients with two liquid-filled intragastric balloon systems used to treat obesity, the FDA announced on June 4. ... hyperinflation. The FDA continues to work with device manufacturers Apollo Endosurgery and
The FDA on Jan. 26 approved the first radioactive drug to treat a rare group of cancers called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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 ... The FDA has approved new warnings for the 10-mg twice-daily dose of tofacitinib (Xeljanz,
The three-drug combination injection contains imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor. ... The three-drug combination injection (Recarbrio) contains imipenem-cilastatin, a previously
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 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
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.
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