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.
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
The FDA on Feb. 28 approved telotristat ethyl (Xermelo) tablets, in combination with somatostatin analog (SSA) therapy, to treat adults with carcinoid syndrome diarrhea that is inadequately controlled with SSA therapy