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
Pink SheetRare diseases are almost certain to remain one of the biggest areas for novel drug development in 2024, but the orphan drug pipeline will be making space for some novel therapies for common conditions
Pink SheetThe month of March will bring eight more chances for the US FDA to approve novel drugs and biologics, potentially providing a corrective to 2024’s slow start for innovative approvals. The number of us
In VivoA beneficial effect of sponsorship by the largest companies in the pharma industry can be seen in the fates of novel agent applications that faced US FDA approval decisions in recent years: the applic