As partners Atara Biotherapeutics and Pierre Fabre Laboratories work to grow the reach of their novel T-cell immunotherapy Ebvallo, a manufacturing-related hitch has tripped up their ambition to ...
Atara on Tuesday announced that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo in Epstein-Barr virus positive post ...
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 ...
These INDs include the EBVALLO TM (tabelecleucel ... and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of ...
Atara Biotherapeutics' cell therapy Ebvallo should be approved to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), according to the EMA's human medicines ...
Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as monotherapy treatment for adult and pediatric patients ...
It closed at $6.93 on Jan. 23. 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 ...
The clinical hold by the FDA is on active investigational new drug applications for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) treatment Ebvallo ...
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 ...