There is typically a flurry of FDA approvals at the end of each year. Although this December was no different, the FDA extended the Prescription Drug User Fee Act (PDUFA) date for two medications that were expecting approval in December 2023: givinostat (Italfarmaco) and donanemab (Eli Lilly). FDA actions also extended the PDUFA dates for other specialty drugs.
The FDA wanted more time to review the data before making a decision about givinostat, a