The FDA has said it cannot approve tabelecleucel to treat patients 2 years of age and older who have EBV-positive PTLD and have received at least 1 prior therapy.
LOS ANGELES - The FDA unveiled a proposal Tuesday to require front-of-package nutrition labels on most packaged foods, a major step in combating chronic diseases. The labels, called "Nutrition ...
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 ...
The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for ...
Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market ...
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 ...
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