The FDA has approved Ferring Pharmaceuticals’ fecal transplant therapy Rebyota for the prevention of recurrence of C. difficile infection (CDI) in individuals that have completed antibiotic treatment for recurrent CDI.…

Eisai’s antiamyloid antibody lecanemab nearly eliminated amyloid brain plaques in 68 percent of Alzheimer’s (AD) patients, while modestly slowing decline on all four cognitive and functional measures in the CLARITY…

In FDA’s ongoing efforts to clean up the accelerated approval (AA) program, the agency has withdrawn approval for an antibiotic cream that’s been on the market for 24 years without…

The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of…

FDA leaders’ efforts to enact meaningful accelerated approval reform — minus any Congressional support — are beginning to show dividends. Source: Drug Industry Daily

Biosimilars with “skinny labeling” saved Medicare $1.5 billion over 5 years, equivalent to almost 5 percent of what the federal system spent on five pricey biologics, according to a new…

The FDA is investigating reports that the osteoporosis medicine Prolia (denosumab) may cause dangerously low calcium levels in the blood of patients with advanced kidney disease, particularly those on dialysis.…

A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual…

The FDA is not extending its enforcement discretion policy for Investigational New Drug (IND) requirements governing the use of fecal microbiota for transplantation (FMT) obtained from stool banks for treatment…

Spectrum Pharmaceuticals, receiving yet another blow from the FDA on its cancer therapy candidate, poziotinib, has announced that it will drop its poziotinib program and is laying off 75 percent…