Pink SheetContract manufacturing of biologics is one of the few weak points in the typically overwhelming advantage the US holds over Europe in bestowing the first approval for new drug products, a Pink Sheet
Pink SheetThe regenerative medicine sector continues to seek increased contact with the US Food and Drug Administration, even as the architects of the Center for Biologics Evaluation and Research review structu
ScripAtara Biotherapeutics is putting the key back in the ignition for Ebvallo (tabelecleucel) as the US Food and Drug Administration has lifted the clinical hold that it placed on the program in January,
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