Atara 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, sending the US biotech’s shares through the floor and threatening its survival.
Atara In Disarray As Shares Sink On Ebvallo CRL
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
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