Pink SheetDespite the ongoing upheaval across the agency, the US Food and Drug Administration maintained its typical reliability when it came to meeting user fee goal dates in the first quarter of 2025, the Pi
ScripAtara Biotherapeutics' hopes of getting Ebvallo approved soon in the US have been dashed after the Food and Drug Administration rejected the off-the-shelf cell therapy due to manufacturing issues, sen
ScripAtara Biotherapeutics’ troubles have deepened as, in the space of less than a week, the US Food and Drug Administration followed a complete response letter (CRL) with a clinical hold on its active inv
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