July 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
The FDA approved tebipenem pivoxil (Utebzi) for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options.
June 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
The FDA approved cefepime and zidebactam (Zaynich, Wockhardt), a novel intravenous antibiotic, for adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible...
On November 10, the U.S. Department of Health and Human Services announced that the FDA is initiating the removal of certain black box warnings from hormone replacement therapy products for menopause,...
The FDA announced the approval of darolutamide for treating metastatic castration-sensitive prostate cancer. This review was conducted under Project Orbis, which allows for concurrent submission and review...
