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 ...
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 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 ...
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 ...
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 ...
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 ...
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 ...