FDA rejects second application for off-the-shelf T-cell therapy
The US Food and Drug Administration (FDA) said it is unable to approve the Atara Biotherapeutics’ off-the-shelf” allogeneic T-cell immunotherapy Ebvallo (tabelecleucel) based on the company’s Biologics License Application (BLA). The regulator ruled that the single arm ALLELE trial, which Atara’s says was previously confirmed by the… Read More