Pink SheetVinay Prasad, director of the US Food and Drug Administration’s Center for Biological Evaluation and Research, defended his recent decisions to overrule reviewers and grant narrower indications to thr
Pink SheetWith 22 novel agents approved in the first six months of 2025, the US FDA is already behind its average approval count for the first half of the year, and the user fee calendar for the second half doe
ScripAn update to the label for Moderna’s Spikevax COVID-19 vaccine giving it full approval for young children reflects the overall more skeptical stance of the Trump Administration toward vaccines. And wh
ScripThe recent removal of the Risk Evaluation and Mitigation Strategies (REMS) requirement for approved cellular CAR-T therapies for cancer was lauded as an expansion of the market from the two-in-10 el