The manufacturers have not fulfilled requirements to conduct studies assessing the real-world effectiveness of device reprocessing, the FDA said.
The FDA's recommendation follows a study finding that sodium polystyrene sulfonate also binds to many common oral medications, which decreases ...
In a letter to clinicians, the FDA noted five reports of unanticipated deaths that occurred from 2016 to the present in patients treated with liquid-filled intragastric ...
Approved use of the drug has been expanded to include treatment of patients with hepatocellular carcinoma who have been treated with sorafenib.
The agency is working with manufacturers to use blister packs or other single-dose packaging and curb the number of doses contained in each ...
The changes aim to reduce the potential for patient fluids to leak into the closed elevator channel and underneath the distal cap.
The drug is the first FDA-approved biosimilar to treat breast or stomach cancer and the second FDA-approved biosimilar to treat cancer.
The FDA suggests that clinicians should consider alternatives to eluxadoline in this population.
Clinicians should determine baseline liver function before starting patients on obeticholic acid, the FDA said.
The oral medication is taken once per day and works in the upper GI tract to stimulate secretion of intestinal fluid, supporting regular bowel function.