FiercePharma13d
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 ...
Business Wire13d
Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219
These INDs include the EBVALLO TM (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant ...
Hosted on MSN11d
Atara’s T cell programmes hit with clinical hold after third-party site woes
The clinical hold by the FDA is on active investigational new drug applications for Epstein-Barr virus-positive ...
Atara to cut 50% of workforce amid FDA woes
Atara Biotherapeutics (ATRA) plans to cut around 50% of its workforce, just a little over a week after the FDA declined to ...
sfvbj6d
Atara Biotherapeutics Sees Its Share Price Fall
Atara Biotherapeutics experiences a plunge in share prices after the Food and Drug Administration holds up approval of a drug ...
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 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, ...
BioSpace12d
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 ...
BioSpace6d
Atara to Cut Half Its Workforce Following FDA-Related Setbacks
Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected Ebvallo, a T cell therapy approved in Europe for a transplant-related blood ...
Seeking Alpha13d
Atara Biotherapeutics: Another Dip Buying Opportunity Following CRL For CMC Issues
Atara has just announced a CRL by FDA for EBVALLO. EBVALLO is already approved in Europe since December 2022 and the cause of the CRL seems minor and easily addressable. The CRL has a major impact ...
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 ...
Los Angeles Business Journal7d
Atara Biotherapeutics Sees Its Share Price Fall
Preceding the sharp decline was the Food and Drug Administration releasing a letter to the company stating concerns about the third-party manufacturer of its blood cancer drug Ebvallo and delaying ...