Pink Sheet“Pipeline in a pill”-style drug development will be on display in April, when more than half of the user fee goal dates are for new indications on sometimes sprawling labels, as well as one novel biol
Pink SheetOne-third of all the regenerative medicine advanced therapy (RMAT) designations granted by the US Food and Drug Administration’s Center for Biologics Evaluation and Research were awarded in fiscal yea
Pink SheetWhile the FDA is facing a disrupted and uncharted future, drug development offers a few certainties, including that oncology and neuroscience still dominate the novel agents seeking approval. But the
Pink SheetThe US Food and Drug Administration maintained a high rate of complete response letter actions for novel agent applications in 2024, but recent history suggests that many of the 16 CRL recipients will