Atara Biotherapeutics Provides Update on Clinical Programs …
3 days ago · U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL). THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop …
Atara hit with cell therapy clinical hold after FDA inspection
3 days ago · Atara linked the hold to a recent FDA inspection of a third-party manufacturing facility for Ebvallo, which resulted in a U.S. rejection of the allogeneic cell therapy.
Atara Biotherapeutics Provides Update on Clinical ... - Business …
4 days ago · Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219 U.S. FDA issues clinical hold on EBVALLO ™ (tabelecleucel) and ATA3219 studies linked ...
Atara Biotherapeutics Provides Update on Clinical ... - Morningstar
4 days ago · Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219 U.S. FDA issues clinical hold on EBVALLO ™ (tabelecleucel) and ATA3219 studies linked ...
Atara Biotherapeutics reports clinical hold placed on Ebvallo …
4 days ago · Atara Biotherapeutics announced that the FDA has placed a clinical hold on Atara’s active investigational new drug, or IND, applications. These INDs include the Ebvallo program as monotherapy ...
Atara Biotherapeutics Receives FDA Complete Response Letter for Ebvallo
4 days ago · NEW YORK – Atara Biotherapeutics last week said the US Food and Drug Administration has issued a complete response to its biologics license application (BLA) seeking approval for Ebvallo (tabelecleucel) as a treatment for Epstein-Barr virus (EBV)-positive posttransplant lymphoproliferative disease (PTLD). ... Once Ebvallo achieves FDA ...
FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell …
4 days ago · FDA places a clinical hold on Atara's EBVALLO and ATA3219 programs due to GMP compliance issues at a third-party facility. Atara to pause new participant enrollment; CAR-T programs may suspend in ...
Atara Biotherapeutics Provides Regulatory and Business Update …
Jan 16, 2025 · EBVALLO, which was granted marketing authorization by the European Commission in December of 2022, is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells.
Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) Receives …
Dec 19, 2022 · Only Approved Therapy for EU Patients with Rare and Potentially Deadly Cancer Facing Median Survival of Only a Few Months. Represents First Approval of an Allogeneic T-Cell Immunotherapy Globally. Pierre Fabre to Lead Commercialization and Distribution Activities in …
Atara Biotherapeutics Provides Update on Clinical Programs
4 days ago · U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL) Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell ...
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