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
The FDA announced on July 18 that it has approved a new drug combination to treat adults with chronic hepatitis C virus (HCV) genotypes 1 through 6 who have mild or ... Due to concerns about hepatitis B virus (HBV) reactivation in co-infected patients,
The FDA has approved the first treatment for hepatocellular carcinoma in nearly a decade, the agency announced on April 27. ... The FDA granted the drug application priority review and designated regorafenib as an orphan drug.
Magno-Humphries Laboratories, Inc., has recalled one lot of Basic Drugs Brand Senna Laxative tablets (8.6-mg sennosides) due to mislabeling, the FDA announced on Jan.
Serious infections have occurred in adults who received investigational fecal microbiota transplantation (FMT) containing multidrug-resistant organisms, the FDA recently warned. ... It's also necessary to test donor stool for multidrug-resistant
safety. Certain connectors used in gastrointestinal endoscopy pose a risk of cross-contamination and are not recommended, the FDA announced on April 18. ... Endoscope connectors that are designed according to FDA recommendations are widely available and
Greenstone has recalled more than a dozen lots of diphenoxylate hydrochloride and atropine sulfate tablets due to potency concerns, the FDA announced on Nov. ... depression, are“ improbable,” according to the FDA.
The drug is the first FDA-approved biosimilar to treat breast or stomach cancer and the second FDA-approved biosimilar to treat cancer. ... Dec. 1. The new drug, trastuzumab-dkst (Ogivri), is the first FDA-approved biosimilar to treat breast or stomach
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 balloon systems. ... On Aug. 10, the FDA released a safety alert about the potential