Search results for "FDA update"

Results 21 - 30 of about 31 for "FDA update".

Sodium polystyrene sulfonate should be taken separately from other oral meds, FDA advises

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
September 2017

Drug for chronic idiopathic constipation approved

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
January 2017

New HCV drug combo approved

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,
July 2017

Regorafenib now FDA-approved to treat hepatocellular carcinoma

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.
May 2017

Batch of senna laxatives recalled

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.
February 2018

FDA update

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
June 2019

FDA alerts clinicians about cross-contamination risk with certain endoscope connectors

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
April 2018

Potency concerns lead to recall of anti-diarrhea drug

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.
November 2017

Biosimilar approved for certain cases of breast, metastatic stomach cancer

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
December 2017

Weight-loss devices linked to patient deaths

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
September 2017

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