As contemporary surgical practice continues to evolve, patients who undergo surgical lung volume reduction (LVRS) for ...
U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL) ...
The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.
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.
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against ...
Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.
The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for ...
Shares of Atara Biotherapeutics, Inc. (NASDAQ:ATRA) tumbled 51% after the company disclosed receiving a Complete Response ...
The U.S. Food and Drug Administration on Thursday declined to approve Atara Biotherapeutics' cancer therapy, chemically ...
Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as ...