U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL) ...
Atara Biotherapeutics, Inc. , a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer ...
The FDA's letter did not point out any deficiencies in the manufacturing process nor did it demand new clinical studies for the approval of EBVALLO. Despite the setback, Atara emphasized its ...
Atara disclosed these specifics in their release. Already authorized in the European Union,EBVALLO is based on data from the key ALLELE trial. According to Atara's announcement, the study revealed a ...
Atara's drug Ebvallo treats a rare form of blood cancer that develops in patients who receive transplants. The company plans to resubmit, and said it expects the drug to be approved within six ...
Atara Biotherapeutics said Thursday that the FDA has turned down its request to start selling its Ebvallo drug across state lines in a complete response letter. The biotechnology company said the ...
Atara Biotherapeutics, Inc. , a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer ...
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