FiercePharma4d
Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...
FiercePharma9d
Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of manufacturing plant's shortfalls
As partners Atara Biotherapeutics and Pierre Fabre Laboratories work to grow the reach of their novel T-cell immunotherapy ...
Hosted on MSN3d
Atara’s T cell programmes hit with clinical hold after third-party site woes
The FDA placed a clinical hold on two Atara assets, following an inspection at a third-party site that also led to a CRL for ...
BioSpace3d
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
Hosted on MSN8d
ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against ...
FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs
On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) ...
Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr ...
Atara Biotherapeutics reports clinical hold placed on Ebvallo programs, ATA3219
Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on Atara’s active investigational new drug, or IND, ...
BioSpace9d
Manufacturing Issues Result in FDA Rejection of Atara’s Cell Therapy
Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market ...
Atara announces Ebvallo CRL did not find clinical efficacy deficiencies
Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as ...
Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLOTM (tabelecleucel)
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr ...
Morningstar5d
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 to EBVALLO Complete Response Letter (CRL) Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell ...