Fourteen user fee goal dates are on the October calendar, including three novel agents, according to the Pink Sheet US FDA Performance Tracker.

Stakeholders differ on whether the rapid growth in spending is to be expected, given the realities in health care and specialty drug costs, or that the data underscores the need for oversight and reform of the 340B program.

EU marketing authorization applications have been submitted for a number of new drugs, including Eli Lilly’s donanemab, Italfarmaco's givinostat and Arcturus Therapeutics/CSL’s ARCT-154.

Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.